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Learning about and prescribing emergency contraception
As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.
When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.
We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.
With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.
EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.
We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.
In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.
As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.
When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.
We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.
With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.
EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.
We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.
In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.
As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.
When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.
We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.
With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.
EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.
We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.
In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.
AAP calls for increased attention on unique health needs of adolescents
Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.
“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.
The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.
Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.
“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.
Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.
, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.
Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.
“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”
The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.
In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.
The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.
Dr. Alderman and Dr. Breuner declared having no conflicts of interest.
SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .
Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.
“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.
The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.
Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.
“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.
Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.
, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.
Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.
“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”
The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.
In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.
The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.
Dr. Alderman and Dr. Breuner declared having no conflicts of interest.
SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .
Adolescence is a critical period of development that brings with it unique health challenges, which has prompted the American Academy of Pediatrics to publish a policy statement addressing those issues.
“The importance of addressing the physical and mental health of adolescents has become more evident, with investigators in recent studies pointing to the fact that unmet health needs during adolescence and in the transition to adulthood predict not only poor health outcomes as adults but also lower quality of life in adulthood,” wrote lead authors Elizabeth M. Alderman, MD, and Cora Collette Breuner, MD, MPH, of the AAP’s Committee on Adolescence.
The first key health risk the authors highlighted was risky and risk-taking behaviors, pointing out that nearly three-quarters of adolescent deaths result from vehicle crashes, injuries from firearms, alcohol and illicit substances, homicide, or suicide. They also cited increased concern about the use of e-cigarettes among adolescents.
Recommendations exist on screening for and counseling on high-risk behaviors, but evidence showing that relatively few adolescents actually receive any kind of preventive counseling or discuss these health risks with pediatricians or primary care physicians suggests that improvement is needed.
“New screening codes for depression, substance use, and alcohol and tobacco use as well as brief intervention services may provide opportunities to receive payment for the services pediatricians are providing to adolescents,” wrote Dr. Alderman of the division of adolescent medicine in the department of pediatrics at Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, New York, and Dr. Breuner of the division of adolescent medicine at the University of Washington and Seattle Children’s Hospital.
Thanks to technological advances in pediatric medical care, more adolescents are being identified with chronic medical conditions and developmental challenges. One survey suggested that as many as 31% of adolescents have one moderate to severe chronic health condition, such as asthma, cardiac disease, HIV, and developmental disabilities. Many, however, have unmet health needs that could affect their physical growth and development during adolescence.
, with evidence suggesting this group of adolescents is at risk of depression because of the isolation and discrimination they experience.
Similarly, the statement acknowledged the growing diversity of adolescent populations – for example, adolescents who identify as lesbian, gay, bisexual, or transgender – and the importance of delivering appropriate care to those populations.
“Sexual orientation and behaviors should be assessed by the pediatrician without making assumptions,” the authors wrote. “Adolescents should be allowed to apply and explain the labels they choose to use for sexuality and gender using open-ended questions.”
The authors drew attention to the greater mental health risks of adolescents, pointing out that about one in five adolescents have a diagnosable mental health disorder and one-quarter of adults with mood disorders had their first major depressive episode during adolescence. They also cited the Centers for Disease Control and Prevention’s 2017 Youth Risk Behavior Survey of high school students, which showed that adolescents with a parent serving in the military are at increased risk of suicidal ideation.
In addition, Dr. Alderman and Dr. Breuner said, mental health problems experienced by adolescents often are comorbid with eating disorders. Formerly obese adolescents, male teenagers, and young people from lower socioeconomic groups are increasingly developing anorexia nervosa, bulimia nervosa, and other disordered eating.
The paper called for more financial, educational, and training support for pediatricians and other health care professionals to enable them to better meet the health and developmental needs of adolescents.
Dr. Alderman and Dr. Breuner declared having no conflicts of interest.
SOURCE: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150 .
FROM PEDIATRICS
Key clinical point: New screening codes for depression, substance use, and other intervention services may make it possible for pediatricians to receive payment for services.
Major finding: Adolescents might have particular health issues around risk-taking behaviors, mental health, and other issues.
Study details: Policy statement from the American Academy of Pediatrics.
Disclosures: No funding or conflicts of interest were declared.
Source: Alderman EM and Breuner CC. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3150.
AAP advises pediatricians to support emergency contraception for all teenagers
Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.
“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.
; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.
In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.
The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.
The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.
The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.
The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.
M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”
“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.
"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.
The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”
“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).
The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active.
Dr. Upadhya disclosed having no financial conflicts.
SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.
This article was updated on 11/19/19 and 12/16/19.
Despite declining teen birth rates, the United States has the highest rate of teen pregnancy among developed nations outside the former Soviet Bloc, according to the Guttmacher Institute. This high rate remains in part because of the significant barriers that prevent access to reproductive health services for adolescents. Teen pregnancy prevention remains an important adolescent health issue because of the high risk of poor health outcomes facing teen parents and their children. As advocates for children, pediatricians should educate, advocate for, and provide contraception to their patients. To this end, the AAP’s policy statement on emergency contraception (EC) provides practical guidance to increase access for EC for adolescents.
Simply put, EC provides contraception for “emergencies” such as unprotected sex, sexual assault, missed birth control pills, and condom failure. While EC is not meant to be the sole form of contraception used by adolescents, it is an important stop-gap measure – and the only one that can be used after sex. The “gold standard” for contraception in teens remains long-acting reversible contraception (LARC) methods such as the intrauterine device and the hormonal implant. These methods are recommended first line by the AAP because of their high efficacy.
Despite these recommendations, LARC use remains low, with only 6% of sexually active U.S. teens using these methods. While pediatricians should continue to encourage LARC methods, they should not neglect counseling on other contraceptive methods, including on EC.
In fact, studies demonstrate that pediatricians often omit counseling about EC, and most do not prescribe these medications routinely. Despite several available over-the-counter formulations, there still are significant barriers to teens in accessing these medications. In my practice, I have experienced teens who miss the opportunity to use this medication because of its cost and nonavailability when it is needed – from either inadequate stock at the pharmacy or from pharmacists’ conscientious objections. Ideally, counseling on EC should be part of the routine anticipatory guidance provided to all adolescents, and routine prescriptions should be given to adolescent women. When I prescribe EC to teens preventively, I tell them to fill the prescription and have it “on hand” at home in case it is ever needed, given the time-sensitive nature of most formulations. This policy also saliently addresses counseling for adolescent men – who often are overlooked in conversations about EC as they cannot use these methods. However, increasing their awareness and knowledge of this method can increase its use in their partners.
This policy provides excellent technical information on different formulations of EC, side effects, contraindications, and anticipatory guidance to give patients about the use of these medications. Additionally, it highlights the copper IUD – the often forgotten, but most effective form of EC that provides lasting pregnancy prevention. Overall, this policy provides great information to “demystify” EC and encourages pediatricians to engage in improving reproductive health access for adolescents.*
Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma Health Sciences Center, Oklahoma City. She was asked to comment on the AAP policy statement on emergency contraception. Dr. Curran is a member of the Pediatric News Editorial Advisory Board. Email her at [email protected].
Despite declining teen birth rates, the United States has the highest rate of teen pregnancy among developed nations outside the former Soviet Bloc, according to the Guttmacher Institute. This high rate remains in part because of the significant barriers that prevent access to reproductive health services for adolescents. Teen pregnancy prevention remains an important adolescent health issue because of the high risk of poor health outcomes facing teen parents and their children. As advocates for children, pediatricians should educate, advocate for, and provide contraception to their patients. To this end, the AAP’s policy statement on emergency contraception (EC) provides practical guidance to increase access for EC for adolescents.
Simply put, EC provides contraception for “emergencies” such as unprotected sex, sexual assault, missed birth control pills, and condom failure. While EC is not meant to be the sole form of contraception used by adolescents, it is an important stop-gap measure – and the only one that can be used after sex. The “gold standard” for contraception in teens remains long-acting reversible contraception (LARC) methods such as the intrauterine device and the hormonal implant. These methods are recommended first line by the AAP because of their high efficacy.
Despite these recommendations, LARC use remains low, with only 6% of sexually active U.S. teens using these methods. While pediatricians should continue to encourage LARC methods, they should not neglect counseling on other contraceptive methods, including on EC.
In fact, studies demonstrate that pediatricians often omit counseling about EC, and most do not prescribe these medications routinely. Despite several available over-the-counter formulations, there still are significant barriers to teens in accessing these medications. In my practice, I have experienced teens who miss the opportunity to use this medication because of its cost and nonavailability when it is needed – from either inadequate stock at the pharmacy or from pharmacists’ conscientious objections. Ideally, counseling on EC should be part of the routine anticipatory guidance provided to all adolescents, and routine prescriptions should be given to adolescent women. When I prescribe EC to teens preventively, I tell them to fill the prescription and have it “on hand” at home in case it is ever needed, given the time-sensitive nature of most formulations. This policy also saliently addresses counseling for adolescent men – who often are overlooked in conversations about EC as they cannot use these methods. However, increasing their awareness and knowledge of this method can increase its use in their partners.
This policy provides excellent technical information on different formulations of EC, side effects, contraindications, and anticipatory guidance to give patients about the use of these medications. Additionally, it highlights the copper IUD – the often forgotten, but most effective form of EC that provides lasting pregnancy prevention. Overall, this policy provides great information to “demystify” EC and encourages pediatricians to engage in improving reproductive health access for adolescents.*
Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma Health Sciences Center, Oklahoma City. She was asked to comment on the AAP policy statement on emergency contraception. Dr. Curran is a member of the Pediatric News Editorial Advisory Board. Email her at [email protected].
Despite declining teen birth rates, the United States has the highest rate of teen pregnancy among developed nations outside the former Soviet Bloc, according to the Guttmacher Institute. This high rate remains in part because of the significant barriers that prevent access to reproductive health services for adolescents. Teen pregnancy prevention remains an important adolescent health issue because of the high risk of poor health outcomes facing teen parents and their children. As advocates for children, pediatricians should educate, advocate for, and provide contraception to their patients. To this end, the AAP’s policy statement on emergency contraception (EC) provides practical guidance to increase access for EC for adolescents.
Simply put, EC provides contraception for “emergencies” such as unprotected sex, sexual assault, missed birth control pills, and condom failure. While EC is not meant to be the sole form of contraception used by adolescents, it is an important stop-gap measure – and the only one that can be used after sex. The “gold standard” for contraception in teens remains long-acting reversible contraception (LARC) methods such as the intrauterine device and the hormonal implant. These methods are recommended first line by the AAP because of their high efficacy.
Despite these recommendations, LARC use remains low, with only 6% of sexually active U.S. teens using these methods. While pediatricians should continue to encourage LARC methods, they should not neglect counseling on other contraceptive methods, including on EC.
In fact, studies demonstrate that pediatricians often omit counseling about EC, and most do not prescribe these medications routinely. Despite several available over-the-counter formulations, there still are significant barriers to teens in accessing these medications. In my practice, I have experienced teens who miss the opportunity to use this medication because of its cost and nonavailability when it is needed – from either inadequate stock at the pharmacy or from pharmacists’ conscientious objections. Ideally, counseling on EC should be part of the routine anticipatory guidance provided to all adolescents, and routine prescriptions should be given to adolescent women. When I prescribe EC to teens preventively, I tell them to fill the prescription and have it “on hand” at home in case it is ever needed, given the time-sensitive nature of most formulations. This policy also saliently addresses counseling for adolescent men – who often are overlooked in conversations about EC as they cannot use these methods. However, increasing their awareness and knowledge of this method can increase its use in their partners.
This policy provides excellent technical information on different formulations of EC, side effects, contraindications, and anticipatory guidance to give patients about the use of these medications. Additionally, it highlights the copper IUD – the often forgotten, but most effective form of EC that provides lasting pregnancy prevention. Overall, this policy provides great information to “demystify” EC and encourages pediatricians to engage in improving reproductive health access for adolescents.*
Kelly Curran, MD, specializes in adolescent medicine at the University of Oklahoma Health Sciences Center, Oklahoma City. She was asked to comment on the AAP policy statement on emergency contraception. Dr. Curran is a member of the Pediatric News Editorial Advisory Board. Email her at [email protected].
Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.
“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.
; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.
In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.
The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.
The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.
The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.
The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.
M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”
“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.
"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.
The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”
“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).
The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active.
Dr. Upadhya disclosed having no financial conflicts.
SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.
This article was updated on 11/19/19 and 12/16/19.
Educating pediatricians to inform their teenage patients about emergency contraception is an important step toward reducing adolescent pregnancy in the United States, according to a policy statement issued by the American Academy of Pediatrics.
“Improved use of contraception, not declines in sexual activity, has been the most significant contributor to the decline in pregnancy risk among U.S. teenagers over the past decade,” wrote Krishna K. Upadhya, MD, MPH, and colleagues on the AAP’s Committee on Adolescence.
; however, many pediatricians do not routinely counsel adolescents about emergency contraception, they noted.
In the statement published Nov. 18 in Pediatrics, the committee listed indications for emergency contraception as unprotected or underprotected intercourse for reasons including sexual assault, lack of contraception use, or ineffective contraception use. The committee recommended that pediatricians provide emergency contraception in the form of oral pills (levonorgestrel or ulipristal acetate) or copper IUDs to adolescents in immediate need of emergency contraception, and ideally, to make those products available in advance so teens have them on hand.
The committee recommended the use of combined contraceptive pills known as the Yuzpe method, if dedicated emergency contraceptive pills or IUDs are not available, and emphasized the possible impact of overweight and obesity on the effectiveness of emergency contraceptive pills.
The recommendations also include advising adolescents about proper use of emergency contraception, and the need for follow-up visits to address ongoing contraception and testing for sexually transmitted diseases. The committee noted that adolescents using emergency contraceptive pills must be counseled to abstain or use additional contraception (such as condoms) because of the delay in ovulation associated with these products.
The committee recommended that all adolescents receive counseling on emergency contraception as part of a general discussion on sexual health, regardless of current sexual activity or lack of it. “In addition, it is important that information about EC be included in all contraceptive and STI counseling for adolescents wherever these visits occur, including emergency departments, clinics, and hospitals,” and that pediatricians provide this information to teens with physical and cognitive disabilities and their parents as well, they wrote.
The committee concluded the recommendations by asking clinicians to advocate for free or inexpensive nonprescription access to emergency contraceptive pills for adolescents regardless of age and insurance status.
M. Susan Jay, MD, program director of adolescent health and medicine at the Children’s Hospital of Wisconsin, Milwaukee, commented in an interview, “Forty years ago, as I completed my training, I don’t believe it would have been possible to contemplate the growth of adolescent health care, including reproductive health care that current pediatric practitioners are asked to provide to the adolescents under their care.”
“Today we are asked to be a resource from topics related to vaping and trafficking as well as psychosocial concerns from anxiety to eating disorders. This policy statement from the AAP addresses how best to approach and counsel both young women and young men as they traverse the issues of sexual engagement and responsibility. I have been privileged to work with pediatric residents who are far more sophisticated and knowledgeable than I have ever been, but they call and ask the very questions so adroitly presented in this policy statement. Most of my pediatric colleagues have had a limited adolescent medicine experience, and yet they are asked to care for youth in sensitive situations and want the tools necessary to provide the very best and safest care to their patients. Most of us will not be skilled in the placement of copper IUDs as outlined as an option for emergency contraception, but knowledge of the medications reviewed is of importance and relevant to everyday practice.
"This policy statement is a resource and educational update rolled into one, and Dr. Upadhya and her colleagues on the AAP’s Committee on Adolescence should be commended for assisting providers to offer the best and safest care,” said Dr. Jay, who was not involved in writing the AAP policy statement, and is a member of the Pediatric News Editorial Advisory Board who was asked to comment on the new policy statement.
The American College of Pediatricians (ACPeds), a conservative-leaning pediatric organization opposes the AAP’s recent opinion and the provision of emergency contraception to youth, Michelle Cretella, MD, executive director for the group, said in an interview. In its own position statement, ACPeds wrote that preprescribing EC to adolescent patients, or making them available without prescription, “carries significant medical risk and is counterproductive to the parent-adolescent and patient-physician relationships.”
“Increased access to [EC] does not result in lower pregnancy rates among adolescents and young adults,” said Dr. Cretella, a board-certified pediatrician who is not currently in practice. The ACPeds position statement cites a 2012 study that examined a Washington state program that allowed patients to access EC through pharmacies without a prescription. The analysis found the increased access to EC resulted in a statistically significant rise in gonorrhea for women and overall for both genders. The increased access to EC did not impact birth rates or abortion rates, according to the study (Economic Inquiry. 2013 Jul;51[3]:1682-95).
The ACPeds statement also notes a report by the Heritage Foundation that found sexually active teenagers were less likely to be happy and more likely to be depressed than were youth who were not having sex. The 2003 report, which examined responses from 6,500 adolescents through the 1996 National Longitudinal Survey of Adolescent Health, also found that sexually active teenagers were significantly more likely to attempt suicide, compared with teens who were not sexually active.
Dr. Upadhya disclosed having no financial conflicts.
SOURCE: Upadhya KK et al. Pediatrics. 2019 Nov 18. doi: 10.1542/peds.2019-3149.
This article was updated on 11/19/19 and 12/16/19.
FROM PEDIATRICS
Are you operating in the black when it comes to vaccine administration?
NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.
Another is to make sure that you join an effectively managed and effective group purchasing organization.
Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.
said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”
Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.
“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”
How to determine your vaccine product overhead
There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.
“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.
Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.
On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.
How to make sure you are operating in the red
Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”
Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.
Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”
Mr. Hart reported having no relevant financial disclosures.
NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.
Another is to make sure that you join an effectively managed and effective group purchasing organization.
Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.
said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”
Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.
“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”
How to determine your vaccine product overhead
There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.
“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.
Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.
On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.
How to make sure you are operating in the red
Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”
Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.
Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”
Mr. Hart reported having no relevant financial disclosures.
NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.
Another is to make sure that you join an effectively managed and effective group purchasing organization.
Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.
said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”
Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.
“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”
How to determine your vaccine product overhead
There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.
“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.
Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.
On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.
How to make sure you are operating in the red
Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”
Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.
Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”
Mr. Hart reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM AAP 19
Pediatricians uniquely qualified to treat adolescents with opioid use disorder
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
EXPERT ANALYSIS FROM AAP 19
More adolescents seek medical care for mental health issues
Less than a decade ago, the ED at Rady Children’s Hospital in San Diego would see maybe one or two young psychiatric patients per day, said Benjamin Maxwell, MD, the hospital’s interim director of child and adolescent psychiatry.
Now, it’s not unusual for the ED to see 10 psychiatric patients in a day, and sometimes even 20, said Dr. Maxwell. “What a lot of times is happening now is kids aren’t getting the care they need, until it gets to the point where it is dangerous.”
EDs throughout California are reporting a sharp increase in adolescents and young adults seeking care for a mental health crisis. In 2018, California EDs treated 84,584 young patients aged 13-21 years who had a primary diagnosis involving mental health. That is up from 59,705 in 2012, a 42% increase, according to data provided by the Office of Statewide Health Planning and Development.
By comparison, the number of ED encounters among that age group for all other diagnoses grew by just 4% over the same period. And the number of encounters involving mental health among all other age groups – everyone except adolescents and young adults – rose by about 18%.
The spike in youth mental health visits corresponds with a recent survey that found that members of “Generation Z” – defined in the survey as people born since 1997 – are more likely than other generations to report their mental health as fair or poor. The 2018 polling, done on behalf of the American Psychological Association, also found that members of Generation Z, along with millennials, are more likely to report receiving treatment for mental health issues.
The trend corresponds with another alarming development, as well: a marked increase in suicides among teens and young adults. About 7.5 of every 100,000 young people aged 13-21 in California died by suicide in 2017, up from a rate of 4.9 per 100,000 in 2008, according to the latest figures from the Centers for Disease Control and Prevention. Nationwide, suicides in that age range rose from 7.2 to 11.3 per 100,000 from 2008 to 2017.
Researchers are studying the causes for the surging reports of mental distress among America’s young people. Many recent theories note that the trend parallels the rise of social media, an ever-present window on peer activities that can exacerbate adolescent insecurities and open new avenues of bullying.
“Even though this generation has been raised with social media, youth are feeling more disconnected, judged, bullied, and pressured from their peers,” said Susan Coats, EdD, a school psychologist at Baldwin Park Unified School District near Los Angeles.
“Social media: It’s a blessing and it’s a curse,” Dr. Coats added. “Social media has brought youth together in a forum where maybe they may have felt isolated before, but it also has undermined interpersonal relationships.”
Members of Generation Z also report significant levels of stress about personal debt, housing instability, and hunger, as well as mass shootings and climate change, according to the American Psychological Association survey.
“We’re not doing a great job with … catching things before they devolve into broader problems, and we’re not doing a good job with prevention,” said Lishaun Francis, associate director of health collaborations at Children Now, a nonprofit based in Oakland, Calif.
Many California school districts don’t have enough school psychologists and don’t devote enough resources to teaching students how to cope with depression, anxiety, and other mental health issues, said Ms. Coats, who chairs the mental health and crisis consultation committee of the California Association of School Psychologists.
In the broader community, medical providers also are struggling to keep up. “Many times there aren’t psychiatric beds available for kids in our community,” Dr. Maxwell said.
Most of the adolescents who come into the ED at Rady Children’s Hospital during a mental health crisis are considering suicide, have attempted suicide, or have harmed themselves, said Dr. Maxwell, who is also the hospital’s medical director of inpatient psychiatry.
These patients are triaged and quickly seen by a social worker. Often, a behavioral health assistant is assigned to sit with the patients throughout their stay.
“Suicidal patients – we don’t want them to be alone at all in a busy emergency department,” Dr. Maxwell said. “So that’s a major staffing increase.”
Rady Children’s Hospital plans to open a six-bed, 24-hour psychiatric ED in the spring. Improving emergency care will help, Dr. Maxwell said, but a better solution would be to intervene with young people before they need an ED.
“The ED surge probably represents a failure of the system at large,” Dr. Maxwell said. “They’re ending up in the emergency department because they’re not getting the care they need, when they need it.”
Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University–Sacramento. This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Less than a decade ago, the ED at Rady Children’s Hospital in San Diego would see maybe one or two young psychiatric patients per day, said Benjamin Maxwell, MD, the hospital’s interim director of child and adolescent psychiatry.
Now, it’s not unusual for the ED to see 10 psychiatric patients in a day, and sometimes even 20, said Dr. Maxwell. “What a lot of times is happening now is kids aren’t getting the care they need, until it gets to the point where it is dangerous.”
EDs throughout California are reporting a sharp increase in adolescents and young adults seeking care for a mental health crisis. In 2018, California EDs treated 84,584 young patients aged 13-21 years who had a primary diagnosis involving mental health. That is up from 59,705 in 2012, a 42% increase, according to data provided by the Office of Statewide Health Planning and Development.
By comparison, the number of ED encounters among that age group for all other diagnoses grew by just 4% over the same period. And the number of encounters involving mental health among all other age groups – everyone except adolescents and young adults – rose by about 18%.
The spike in youth mental health visits corresponds with a recent survey that found that members of “Generation Z” – defined in the survey as people born since 1997 – are more likely than other generations to report their mental health as fair or poor. The 2018 polling, done on behalf of the American Psychological Association, also found that members of Generation Z, along with millennials, are more likely to report receiving treatment for mental health issues.
The trend corresponds with another alarming development, as well: a marked increase in suicides among teens and young adults. About 7.5 of every 100,000 young people aged 13-21 in California died by suicide in 2017, up from a rate of 4.9 per 100,000 in 2008, according to the latest figures from the Centers for Disease Control and Prevention. Nationwide, suicides in that age range rose from 7.2 to 11.3 per 100,000 from 2008 to 2017.
Researchers are studying the causes for the surging reports of mental distress among America’s young people. Many recent theories note that the trend parallels the rise of social media, an ever-present window on peer activities that can exacerbate adolescent insecurities and open new avenues of bullying.
“Even though this generation has been raised with social media, youth are feeling more disconnected, judged, bullied, and pressured from their peers,” said Susan Coats, EdD, a school psychologist at Baldwin Park Unified School District near Los Angeles.
“Social media: It’s a blessing and it’s a curse,” Dr. Coats added. “Social media has brought youth together in a forum where maybe they may have felt isolated before, but it also has undermined interpersonal relationships.”
Members of Generation Z also report significant levels of stress about personal debt, housing instability, and hunger, as well as mass shootings and climate change, according to the American Psychological Association survey.
“We’re not doing a great job with … catching things before they devolve into broader problems, and we’re not doing a good job with prevention,” said Lishaun Francis, associate director of health collaborations at Children Now, a nonprofit based in Oakland, Calif.
Many California school districts don’t have enough school psychologists and don’t devote enough resources to teaching students how to cope with depression, anxiety, and other mental health issues, said Ms. Coats, who chairs the mental health and crisis consultation committee of the California Association of School Psychologists.
In the broader community, medical providers also are struggling to keep up. “Many times there aren’t psychiatric beds available for kids in our community,” Dr. Maxwell said.
Most of the adolescents who come into the ED at Rady Children’s Hospital during a mental health crisis are considering suicide, have attempted suicide, or have harmed themselves, said Dr. Maxwell, who is also the hospital’s medical director of inpatient psychiatry.
These patients are triaged and quickly seen by a social worker. Often, a behavioral health assistant is assigned to sit with the patients throughout their stay.
“Suicidal patients – we don’t want them to be alone at all in a busy emergency department,” Dr. Maxwell said. “So that’s a major staffing increase.”
Rady Children’s Hospital plans to open a six-bed, 24-hour psychiatric ED in the spring. Improving emergency care will help, Dr. Maxwell said, but a better solution would be to intervene with young people before they need an ED.
“The ED surge probably represents a failure of the system at large,” Dr. Maxwell said. “They’re ending up in the emergency department because they’re not getting the care they need, when they need it.”
Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University–Sacramento. This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Less than a decade ago, the ED at Rady Children’s Hospital in San Diego would see maybe one or two young psychiatric patients per day, said Benjamin Maxwell, MD, the hospital’s interim director of child and adolescent psychiatry.
Now, it’s not unusual for the ED to see 10 psychiatric patients in a day, and sometimes even 20, said Dr. Maxwell. “What a lot of times is happening now is kids aren’t getting the care they need, until it gets to the point where it is dangerous.”
EDs throughout California are reporting a sharp increase in adolescents and young adults seeking care for a mental health crisis. In 2018, California EDs treated 84,584 young patients aged 13-21 years who had a primary diagnosis involving mental health. That is up from 59,705 in 2012, a 42% increase, according to data provided by the Office of Statewide Health Planning and Development.
By comparison, the number of ED encounters among that age group for all other diagnoses grew by just 4% over the same period. And the number of encounters involving mental health among all other age groups – everyone except adolescents and young adults – rose by about 18%.
The spike in youth mental health visits corresponds with a recent survey that found that members of “Generation Z” – defined in the survey as people born since 1997 – are more likely than other generations to report their mental health as fair or poor. The 2018 polling, done on behalf of the American Psychological Association, also found that members of Generation Z, along with millennials, are more likely to report receiving treatment for mental health issues.
The trend corresponds with another alarming development, as well: a marked increase in suicides among teens and young adults. About 7.5 of every 100,000 young people aged 13-21 in California died by suicide in 2017, up from a rate of 4.9 per 100,000 in 2008, according to the latest figures from the Centers for Disease Control and Prevention. Nationwide, suicides in that age range rose from 7.2 to 11.3 per 100,000 from 2008 to 2017.
Researchers are studying the causes for the surging reports of mental distress among America’s young people. Many recent theories note that the trend parallels the rise of social media, an ever-present window on peer activities that can exacerbate adolescent insecurities and open new avenues of bullying.
“Even though this generation has been raised with social media, youth are feeling more disconnected, judged, bullied, and pressured from their peers,” said Susan Coats, EdD, a school psychologist at Baldwin Park Unified School District near Los Angeles.
“Social media: It’s a blessing and it’s a curse,” Dr. Coats added. “Social media has brought youth together in a forum where maybe they may have felt isolated before, but it also has undermined interpersonal relationships.”
Members of Generation Z also report significant levels of stress about personal debt, housing instability, and hunger, as well as mass shootings and climate change, according to the American Psychological Association survey.
“We’re not doing a great job with … catching things before they devolve into broader problems, and we’re not doing a good job with prevention,” said Lishaun Francis, associate director of health collaborations at Children Now, a nonprofit based in Oakland, Calif.
Many California school districts don’t have enough school psychologists and don’t devote enough resources to teaching students how to cope with depression, anxiety, and other mental health issues, said Ms. Coats, who chairs the mental health and crisis consultation committee of the California Association of School Psychologists.
In the broader community, medical providers also are struggling to keep up. “Many times there aren’t psychiatric beds available for kids in our community,” Dr. Maxwell said.
Most of the adolescents who come into the ED at Rady Children’s Hospital during a mental health crisis are considering suicide, have attempted suicide, or have harmed themselves, said Dr. Maxwell, who is also the hospital’s medical director of inpatient psychiatry.
These patients are triaged and quickly seen by a social worker. Often, a behavioral health assistant is assigned to sit with the patients throughout their stay.
“Suicidal patients – we don’t want them to be alone at all in a busy emergency department,” Dr. Maxwell said. “So that’s a major staffing increase.”
Rady Children’s Hospital plans to open a six-bed, 24-hour psychiatric ED in the spring. Improving emergency care will help, Dr. Maxwell said, but a better solution would be to intervene with young people before they need an ED.
“The ED surge probably represents a failure of the system at large,” Dr. Maxwell said. “They’re ending up in the emergency department because they’re not getting the care they need, when they need it.”
Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University–Sacramento. This Kaiser Health News story first published on California Healthline, a service of the California Health Care Foundation. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
STI update: Testing, treatment, and emerging threats
Sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis are still increasing in incidence and probably will continue to do so in the near future. Moreover, drug-resistant strains of Neisseria gonorrhoeae are emerging, as are less-known organisms such as Mycoplasma genitalium.
Now the good news: new tests for STIs are available or are coming! Based on nucleic acid amplification, these tests can be performed at the point of care, so that patients can leave the clinic with an accurate diagnosis and proper treatment for themselves and their sexual partners. Also, the tests can be run on samples collected by the patients themselves, either swabs or urine collections, eliminating the need for invasive sampling and making doctor-shy patients more likely to come in to be treated.1 We hope that by using these sensitive and accurate tests we can begin to bend the upward curve of STIs and be better antimicrobial stewards.2
This article reviews current issues surrounding STI control, and provides detailed guidance on recognizing, testing for, and treating gonorrhea, chlamydia, trichomoniasis, and M genitalium infection.
STI RATES ARE HIGH AND RISING
STIs are among the most common acute infectious diseases worldwide, with an estimated 1 million new curable cases every day.3 Further, STIs have major impacts on sexual, reproductive, and psychological health.
In the United States, rates of reportable STIs (chlamydia, gonorrhea, and syphilis) are rising.4 In addition, more-sensitive tests for trichomoniasis, which is not a reportable infection in any state, have revealed it to be more prevalent than previously thought.5
BARRIERS AND CHALLENGES TO DIAGNOSIS
The medical system does not fully meet the needs of some populations, including young people and men who have sex with men, regarding their sexual and reproductive health.
Ongoing barriers among young people include reluctance to use available health services, limited access to STI testing, worries about confidentiality, and the shame and stigma associated with STIs.6
Men who have sex with men have a higher incidence of STIs than other groups. Since STIs are associated with a higher risk of human immunodeficiency virus (HIV) infection, it is important to detect, diagnose, and manage STIs in this group—and in all high-risk groups. Rectal STIs are an independent risk factor for incident HIV infection.7 In addition, many men who have sex with men face challenges navigating the emotional, physical, and cognitive aspects of adolescence, a voyage further complicated by mental health issues, unprotected sexual encounters, and substance abuse in many, especially among minority youth.8 These same factors also impair their ability to access resources for preventing and treating HIV and other STIs.
STI diagnosis is often missed
Most people who have STIs feel no symptoms, which increases the importance of risk-based screening to detect these infections.9,10 In many other cases, STIs manifest with nonspecific genitourinary symptoms that are mistaken for urinary tract infection. Tomas et al11 found that of 264 women who presented to an emergency department with genitourinary symptoms or were being treated for urinary tract infection, 175 were given a diagnosis of a urinary tract infection. Of these, 100 (57%) were treated without performing a urine culture; 60 (23%) of the 264 women had 1 or more positive STI tests, 22 (37%) of whom did not receive treatment for an STI.
Poor follow-up of patients and partners
Patients with STIs need to be retested 3 months after treatment to make sure the treatment was effective. Another reason for follow-up is that these patients are at higher risk of another infection within a year.12
Although treating patients’ partners has been shown to reduce reinfection rates, fewer than one-third of STIs (including HIV infections) were recognized through partner notification between 2010 and 2012 in a Dutch study, in men who have sex with men and in women.13 Challenges included partners who could not be identified among men who have sex with men, failure of heterosexual men to notify their partners, and lower rates of partner notification for HIV.
In the United States, “expedited partner therapy” allows healthcare providers to provide a prescription or medications to partners of patients diagnosed with chlamydia or gonorrhea without examining the partner.14 While this approach is legal in most states, implementation can be challenging.15
STI EVALUATION
History and physical examination
A complete sexual history helps in estimating the patient’s risk of an STI and applying appropriate risk-based screening. Factors such as sexual practices, use of barrier protection, and history of STIs should be discussed.
Physical examination is also important. Although some patients may experience discomfort during a genital or pelvic examination, omitting this step may lead to missed diagnoses in women with STIs.16
Laboratory testing
Laboratory testing for STIs helps ensure accurate diagnosis and treatment. Empiric treatment without testing could give a patient a false sense of health by missing an infection that is not currently causing symptoms but that could later worsen or have lasting complications. Failure to test patients also misses the opportunity for partner notification, linkage to services, and follow-up testing.
Many of the most common STIs, including gonorrhea, chlamydia, and trichomoniasis, can be detected using vaginal, cervical, or urethral swabs or first-catch urine (from the initial urine stream). In studies that compared various sampling methods,17 self-collected urine samples for gonorrhea in men were nearly as good as clinician-collected swabs of the urethra. In women, self-collected vaginal swabs for gonorrhea and chlamydia were nearly as good as clinician-collected vaginal swabs. While urine specimens are acceptable for chlamydia testing in women, their sensitivity may be slightly lower than with vaginal and endocervical swab specimens.18,19
A major advantage of urine specimens for STI testing is that collection is noninvasive and is therefore more likely to be acceptable to patients. Urine testing can also be conducted in a variety of nonclinical settings such as health fairs, pharmacy-based screening programs, and express STI testing sites, thus increasing availability.
To prevent further transmission and morbidity and to aid in public health efforts, it is critical to recognize the cause of infectious cervicitis and urethritis and to screen for STIs according to guidelines.12 Table 1 summarizes current screening and laboratory testing recommendations.
GONORRHEA AND CHLAMYDIA
Gonorrhea and chlamydia are the 2 most frequently reported STIs in the United States, with more than 550,000 cases of gonorrhea and 1.7 million cases of chlamydia reported in 2017.4
Both infections present similarly: cervicitis or urethritis characterized by discharge (mucopurulent discharge with gonorrhea) and dysuria. Untreated, they can lead to pelvic inflammatory disease, inflammation, and infertility.
Extragenital infections can be asymptomatic or cause exudative pharyngitis or proctitis. Most people in whom chlamydia is detected from pharyngeal specimens are asymptomatic. When pharyngeal symptoms exist secondary to gonorrheal infection, they typically include sore throat and pharyngeal exudates. However, Komaroff et al,20 in a study of 192 men and women who presented with sore throat, found that only 2 (1%) tested positive for N gonorrhoeae.
Screening for gonorrhea and chlamydia
Best practices include screening for gonorrhea and chlamydia as follows21–23:
- Every year in sexually active women through age 25 (including during pregnancy) and in older women who have risk factors for infection12
- At least every year in men who have sex with men, at all sites of sexual contact (urethra, pharynx, rectum), along with testing for HIV and syphilis
- Every 3 to 6 months in men who have sex with men who have multiple or anonymous partners, who are sexually active and use illicit drugs, or who have partners who use illicit drugs
- Possibly every year in young men who live in high-prevalence areas or who are seen in certain clinical settings, such as STI and adolescent clinics.
Specimens. A vaginal swab is preferred for screening in women. Several studies have shown that self-collected swabs have clinical sensitivity and specificity comparable to that of provider-collected samples.17,24 First-catch urine or endocervical swabs have similar performance characteristics and are also acceptable. In men, urethral swabs or first-catch urine samples are appropriate for screening for urogenital infections.
Testing methods. Testing for both pathogens should be done simultaneously with a nucleic acid amplification test (NAAT). Commercially available NAATs are more sensitive than culture and antigen testing for detecting gonorrhea and chlamydia.25–27
Most assays are approved by the US Food and Drug Administration (FDA) for testing vaginal, urethral, cervical, and urine specimens. Until recently, no commercial assay was cleared for testing extragenital sites, but recommendations for screening extragenital sites prompted many clinical laboratories to validate throat and rectal swabs for use with NAATs, which are more sensitive than culture at these sites.25,28 The recent FDA approval of extragenital specimen types for 2 commercially available assays may increase the availability of testing for these sites.
Data on the utility of NAATs for detecting chlamydia and gonorrhea in children are limited, and many clinical laboratories have not validated molecular methods for testing in children. Current guidelines specific to this population should be followed regarding test methods and preferred specimen types.12,29,30
Although gonococcal infection is usually diagnosed with culture-independent molecular methods, antimicrobial resistance is emerging. Thus, failure of the combination of ceftriaxone and azithromycin should prompt culture-based follow-up testing to determine antimicrobial susceptibility.
Strategies for treatment and control
Historically, people treated for gonorrhea have been treated for chlamydia at the same time, as these diseases tend to go together. This can be with a single intramuscular dose of ceftriaxone for the gonorrhea plus a single oral dose of azithromycin for the chlamydia.12 For patients who have only gonorrhea, this double regimen may help prevent the development of resistant gonorrhea strains.
All the patient’s sexual partners in the previous 60 days should be tested and treated, and expedited partner therapy should be offered if possible. Patients should be advised to have no sexual contact until they complete the treatment, or 7 days after single-dose treatment. Testing should be repeated 3 months after treatment.
M GENITALIUM IS EMERGING
A member of the Mycoplasmataceae family, M genitalium was originally identified as a pathogen in the early 1980s but has only recently emerged as an important cause of STI. Studies indicate that it is responsible for 10% to 20% of cases of nongonococcal urethritis and 10% to 30% of cases of cervicitis.31–33 Additionally, 2% to 22% of cases of pelvic inflammatory disease have evidence of M genitalium.34,35
However, data on M genitalium prevalence are suspect because the organism is hard to identify—lacking a cell wall, it is undetectable by Gram stain.36 Although it has been isolated in respiratory and synovial fluids, it has so far been recognized to be clinically important only in the urogenital tract. It can persist for years in infected patients by exploiting specialized cell-surface structures to invade cells.36 Once inside a cell, it triggers secretion of mycoplasmal toxins and destructive metabolites such as hydrogen peroxide, evading the host immune system as it does so.37
Testing guidelines for M genitalium
Current guidelines do not recommend routine screening for M genitalium, and no commercial test was available until recently.12 Although evidence suggests that M genitalium is independently associated with preterm birth and miscarriages,38 routine screening of pregnant women is not recommended.12
Testing for M genitalium should be considered in cases of persistent or recurrent nongonococcal urethritis in patients who test negative for gonorrhea and chlamydia or for whom treatment has failed.12 Many isolates exhibit genotypic resistance to macrolide antibiotics, which are often the first-line therapy for nongonococcal urethritis.39
Further study is needed to evaluate the potential impact of routine screening for M genitalium on the reproductive and sexual health of at-risk populations.
Diagnostic tests for M genitalium
Awareness of M genitalium as a cause of nongonococcal urethritis has been hampered by a dearth of diagnostic tests.40 The organism’s fastidious requirements and extremely slow growth preclude culture as a practical method of diagnosis.41 Serologic assays are dogged by cross-reactivity and poor sensitivity.42,43 Thus, molecular assays for detecting M genitalium and associated resistance markers are preferred for diagnosis.12
Several molecular tests are approved, available, and in use in Europe for diagnosing M genitalium infection,40 and in January 2019 the FDA approved a molecular test that can detect M genitalium in urine specimens and vaginal, endocervical, urethral, and penile meatal swabs. Although vaginal swabs are preferred for this assay because they have higher sensitivity (92% for provider-collected and 99% for patient-collected swabs), urine specimens are acceptable, with a sensitivity of 78%.44
At least 1 company is seeking FDA clearance for another molecular diagnostic assay for detecting M genitalium and markers of macrolide resistance in urine and genital swab specimens. Such assays may facilitate appropriate treatment.
Clinicians should stay abreast of diagnostic testing options, which are likely to become more readily available soon.
A high rate of macrolide resistance
Because M genitalium lacks a cell wall, antibiotics such as beta-lactams that target cell wall synthesis are ineffective.
Regimens for treating M genitalium are outlined in Table 2.12 Azithromycin is more effective than doxycycline. However, as many as 50% of strains were macrolide-resistant in a cohort of US female patients.45 Given the high incidence of treatment failure with azithromycin 1 g, it is thought that this regimen might select for resistance. For cases in which symptoms persist, a 1- to 2-week course of moxifloxacin is recommended.12 However, this has not been validated by clinical trials, and failures of the 7-day regimen have been reported.46
Partners of patients who test positive for M genitalium should also be tested and undergo clinically applicable screening for nongonococcal urethritis, cervicitis, and pelvic inflammatory disease.12
TRICHOMONIASIS
Trichomoniasis, caused by the parasite Trichomonas vaginalis, is the most prevalent nonviral STI in the United States. It disproportionately affects black women, in whom the prevalence is 13%, compared with 1% in non-Hispanic white women.47 It is also present in 26% of women with symptoms who are seen in STI clinics and is highly prevalent in incarcerated populations. It is uncommon in men who have sex with men.48
In men, trichomoniasis manifests as urethritis, epididymitis, or prostatitis. While most infected women have no symptoms, they may experience vaginitis with discharge that is diffuse, frothy, pruritic, malodorous, or yellow-green. Vaginal and cervical erythema (“strawberry cervix”) can also occur.
Screening for trichomoniasis
Current guidelines of the US Centers for Disease Control and Prevention (CDC) recommend testing for T vaginalis in women who have symptoms and routinely screening in women who are HIV-positive, regardless of symptoms. There is no evidence to support routine screening of pregnant women without symptoms, and pregnant women who do have symptoms should be evaluated according to the same guidelines as for nonpregnant women.12 Testing can be considered in patients who have no symptoms but who engage in high-risk behaviors and in areas of high prevalence.
A lack of studies using sensitive methods for T vaginalis detection has hampered a true estimation of disease burden and at-risk populations. Screening recommendations may evolve in upcoming clinical guidelines as the field advances.
As infection can recur, women should be retested 3 months after initial diagnosis.12
NAAT is the preferred test for trichomoniasis
Commercially available diagnostic tests for trichomoniasis include culture, antigen testing, and NAAT.49 While many clinicians do their own wet-mount microscopy for a rapid result, this method has low sensitivity.50 Similarly, antigen testing and culture perform poorly compared with NAATs, which are the gold standard for detection.51,52 A major advantage of NAATs for T vaginalis detection is that they combine high sensitivity and fast results, facilitating diagnosis and appropriate treatment of patients and their partners.
In spite of these benefits, adoption of molecular diagnostic testing for T vaginalis has lagged behind that for chlamydia and gonorrhea.53 FDA-cleared NAATs are available for testing vaginal, cervical, or urine specimens from women, but until recently, there were no approved assays for testing in men. The Cepheid Xpert TV assay, which is valid for male urine specimens to diagnose other sexually transmitted diseases, has demonstrated excellent diagnostic sensitivity for T vaginalis in men and women.54 Interestingly, a large proportion of male patients in this study had no symptoms, suggesting that screening of men in high-risk groups may be warranted.
7-day metronidazole treatment beats single-dose treatment
The first-line treatment for trichomoniasis has been a single dose of metronidazole 2 g by mouth, but in a recent randomized controlled trial,55 a course of 500 mg by mouth twice a day for 7 days was 45% more effective at 4 weeks than a single dose, and it should now be the preferred regimen.
In clinical trials,56 a single dose of tinidazole 2 g orally was equivalent or superior to metronidazole 2 g and had fewer gastrointestinal side effects, but it is more expensive.
- Harding-Esch EM, Nori AV, Hegazi A, et al. Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation. Sex Transm Infect 2017; 93(6):424–429. doi:10.1136/sextrans-2016-052988
- Unemo M, Bradshaw CS, Hocking JS, et al. Sexually transmitted infections: challenges ahead. Lancet Infect Dis 2017; 17(8):e235–e279. doi:10.1016/S1473-3099(17)30310-9
- Newman L, Rowley J, Vander Hoorn S, et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One 2015; 10(12):e0143304. doi:10.1371/journal.pone.0143304
- Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2017. www.cdc.gov/std/stats17/toc.htm. Accessed October 7, 2019.
- Ginocchio CC, Chapin K, Smith JS, et al. Prevalence of Trichomonas vaginalis and coinfection with Chlamydia trachomatis and Neisseria gonorrhoeae in the United States as determined by the Aptima Trichomonas vaginalis nucleic acid amplification assay. J Clin Microbiol 2012; 50(8):2601–2608. doi:10.1128/JCM.00748-12
- Newton-Levinson A, Leichliter JS, Chandra-Mouli V. Sexually transmitted infection services for adolescents and youth in low- and middle-income countries: perceived and experienced barriers to accessing care. J Adolesc Health 2016; 59(1):7–16.
doi:10.1016/j.jadohealth.2016.03.014 - Barbee LA, Khosropour CM, Dombrowksi JC, Golden MR. New human immunodeficiency virus diagnosis independently associated with rectal gonorrhea and chlamydia in men who have sex with men. Sex Transm Dis 2017; 44(7):385–389. doi:10.1097/OLQ.0000000000000614
- Halkitis PN, Kapadia F, Bub KL, Barton S, Moreira AD, Stults CB. A longitudinal investigation of syndemic conditions among young gay, bisexual, and other MSM: the P18 cohort study. AIDS Behav 2015; 19(6):970–980. doi:10.1007/s10461-014-0892-y
- Farley TA, Cohen DA, Elkins W. Asymptomatic sexually transmitted diseases: the case for screening. Prev Med 2003; 36(4):502–509. pmid:12649059
- Patel P, Bush T, Mayer K, et al; SUN Study Investigators. Routine brief risk-reduction counseling with biannual STD testing reduces STD incidence among HIV-infected men who have sex with men in care. Sex Transm Dis 2012; 39(6):470–474. doi:10.1097/OLQ.0b013e31824b3110
- Tomas ME, Getman D, Donskey CJ, Hecker MT. Overdiagnosis of urinary tract infection and underdiagnosis of sexually transmitted infection in adult women presenting to an emergency department. J Clin Microbiol 2015; 53(8):2686–2692. doi:10.1128/JCM.00670-15
- Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64(RR–03): 1–137. pmid:26042815
- van Aar F, van Weert Y, Spijker R, Gotz H, Op de Coul E; Partner Notification Group. Partner notification among men who have sex with men and heterosexuals with STI/HIV: different outcomes and challenges. Int J STD AIDS 2015; 26(8):565–573. doi:10.1177/0956462414547398
- Centers for Disease Control and Prevention. Sexually transmitted diseases (STDa): expedited partner therapy. www.cdc.gov/std/ept/. Accessed October 7, 2019.
- Jamison CD, Chang T, Mmeje O. Expedited partner therapy: combating record high sexually transmitted infection rates. Am J Public Health 2018; 108(10):1325–1327. doi:10.2105/AJPH.2018.304570
- Singh RH, Zenilman JM, Brown KM, Madden T, Gaydos C, Ghanem KG. The role of physical examination in diagnosing common causes of vaginitis: a prospective study. Sex Transm Infect 2013; 89(3):185–190. doi:10.1136/sextrans-2012-050550
- Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One 2015; 10(7):e0132776. doi:10.1371/journal.pone.0132776
- Michel CE, Sonnex C, Carne CA, et al. Chlamydia trachomatis load at matched anatomic sites: implications for screening strategies. J Clin Microbiol 2007; 45(5):1395–1402. doi:10.1128/JCM.00100-07
- Schachter J, Chernesky MA, Willis DE, et al. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis 2005; 32(12):725–728. pmid:16314767
- Komaroff AL, Aronson MD, Pass TM, Ervin CT. Prevalence of pharyngeal gonorrhea in general medical patients with sore throats. Sex Transm Dis 1980; 7(3):116–119. pmid:6777884
- Centers for Disease Control and Prevention. Clinic-based testing for rectal and pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections by community-based organizations—five cities, United States, 2007. MMWR Morb Mortal Wkly Rep 2009; 58(26):716–719. pmid:19590491
- Chesson HW, Bernstein KT, Gift TL, Marcus JL, Pipkin S, Kent CK. The cost-effectiveness of screening men who have sex with men for rectal chlamydial and gonococcal infection to prevent HIV Infection. Sex Transm Dis 2013; 40(5):366–471. doi:10.1097/OLQ.0b013e318284e544
- Park J, Marcus JL, Pandori M, Snell A, Philip SS, Bernstein KT. Sentinel surveillance for pharyngeal chlamydia and gonorrhea among men who have sex with men—San Francisco, 2010. Sex Transm Dis 2012; 39(6):482–484. doi:10.1097/OLQ.0b013e3182495e2f
- Masek BJ, Arora N, Quinn N, et al. Performance of three nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of self-collected vaginal swabs obtained via an internet-based screening program. J Clin Microbiol 2009; 47(6):1663–1667. doi:10.1128/JCM.02387-08
- Bachmann LH, Johnson RE, Cheng H, et al. Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. J Clin Microbiol 2010; 48(5):1827–1832. doi:10.1128/JCM.02398-09
- Mimiaga MJ, Mayer KH, Reisner SL, et al. Asymptomatic gonorrhea and chlamydial infections detected by nucleic acid amplification tests among Boston area men who have sex with men. Sex Transm Dis 2008; 35(5):495–498. doi:10.1097/OLQ.0b013e31816471ae
- Schachter J, Moncada J, Liska S, Shayevich C, Klausner JD. Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis 2008; 35(7):637–642. doi:10.1097/OLQ.0b013e31817bdd7e
- Cornelisse VJ, Chow EP, Huffam S, et al. Increased detection of pharyngeal and rectal gonorrhea in men who have sex with men after transition from culture to nucleic acid amplification testing. Sex Transm Dis 2017; 44(2):114–117. doi:10.1097/OLQ.0000000000000553
- Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae—2014. MMWR Recomm Rep 2014; 63(RR–02):1–19. pmid:24622331
- Hammerschlag MR, Gaydos CA. Guidelines for the use of molecular biological methods to detect sexually transmitted pathogens in cases of suspected sexual abuse in children. Methods Mol Biol 2012; 903:307–317. doi:10.1007/978-1-61779-937-2_21
- Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Hobbs MM. Mycoplasma genitalium detected by transcription-mediated amplification is associated with Chlamydia trachomatis in adolescent women. Sex Transm Dis 2008; 35(3):250–254. doi:10.1097/OLQ.0b013e31815abac6
- Pond MJ, Nori AV, Witney AA, Lopeman RC, Butcher PD, Sadiq ST. High prevalence of antibiotic-resistant Mycoplasma genitalium in nongonococcal urethritis: the need for routine testing and the inadequacy of current treatment options. Clin Infect Dis 2014; 58(5):631–637. doi:10.1093/cid/cit752
- Seña AC, Lee JY, Schwebke J, et al. A silent epidemic: the prevalence, incidence and persistence of Mycoplasma genitalium among young, asymptomatic high-risk women in the United States. Clin Infect Dis 2018; 67(1):73–79. doi:10.1093/cid/ciy025
- Bjartling C, Osser S, Persson K. The association between Mycoplasma genitalium and pelvic inflammatory disease after termination of pregnancy. BJOG 2010; 117(3):361–364. doi:10.1111/j.1471-0528.2009.02455.x
- Cohen CR, Manhart LE, Bukusi EA, et al. Association between Mycoplasma genitalium and acute endometritis. Lancet 2002; 359(9308):765–766. doi:10.1016/S0140-6736(02)07848-0
- Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Microbiol Rev 2011; 24(3):498–514. doi:10.1128/CMR.00006-11
- Ross JD, Jensen JS. Mycoplasma genitalium as a sexually transmitted infection: implications for screening, testing, and treatment. Sex Transm Infect 2006; 82(4):269–271. doi:10.1136/sti.2005.017368
- Donders GG, Ruban K, Bellen G, Petricevic L. Mycoplasma/ureaplasma infection in pregnancy: to screen or not to screen. J Perinat Med 2017; 45(5):505–515. doi:10.1515/jpm-2016-0111
- Allan-Blitz LT, Mokany E, Miller S, Wee R, Shannon C, Klausner JD. Prevalence of Mycoplasma genitalium and azithromycin-resistant infections among remnant clinical specimens, Los Angeles. Sex Transm Dis 2018; 45(9):632–635. doi:10.1097/OLQ.0000000000000829
- Munson E. Molecular diagnostics update for the emerging (if not already widespread) sexually transmitted infection agent Mycoplasma genitalium: just about ready for prime time. J Clin Microbio. 2017; 55(10):2894–2902. doi:10.1128/JCM.00818-17
- Waites KB, Taylor-Robinson D. Mycoplasma and ureaplasma. In: Jorgensen JH, Pfaller MA, Carroll KC, American Society for Microbiology, eds. Manual of Clinical Microbiology. 11th ed. Washington, DC: ASM Press; 2015:1088–1105.
- Cimolai N, Bryan LE, To M, Woods DE. Immunological cross-reactivity of a Mycoplasma pneumoniae membrane-associated protein antigen with Mycoplasma genitalium and Acholeplasma laidlawii. J Clin Microbiol 1987; 25(11):2136–2139. pmid:2447119
- Ma L, Mancuso M, Williams JA, et al. Extensive variation and rapid shift of the MG192 sequence in Mycoplasma genitalium strains from patients with chronic infection. Infect Immun 2014; 82(3):1326–1334. doi:10.1128/IAI.01526-13
- Hologic. Aptima Mycoplasma genitalium assay.www.hologic.com/sites/default/files/package-insert/AW-14170-001_005_01.pdf. Accessed October 7, 2019.
- Getman D, Jiang A, O’Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 2016; 54(9):2278–2283. doi:10.1128/JCM.01053-16
- Li Y, Le WJ, Li S, Cao YP, Su XH. Meta-analysis of the efficacy of moxifloxacin in treating Mycoplasma genitalium infection. Int J STD AIDS 2017; 28(11):1106–1114. doi:10.1177/0956462416688562
- Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S, Markowitz L. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001–2004. Clin Infect Dis 2007; 45(10):1319–1326. doi:10.1086/522532
- Kelley CF, Rosenberg ES, O’Hara BM, Sanchez T, del Rio C, Sullivan PS. Prevalence of urethral Trichomonas vaginalis in black and white men who have sex with men. Sex Transm Dis 2012; 39(9):739. doi:10.1097/OLQ.0b013e318264248b
- Van Der Pol B. Clinical and laboratory testing for T vaginalis infection. J Clin Microbiol 2016; 54(1):7–12. doi:10.1128/JCM.02025-15
- Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009; 200(2):188.e1–e7. doi:10.1016/j.ajog.2008.10.005
- Andrea SB, Chapin KC. Comparison of Aptima Trichomonas vaginalis transcription-mediated amplification assay and BD affirm VPIII for detection of T. vaginalis in symptomatic women: performance parameters and epidemiological implications. J Clin Microbiol 2011; 49(3):866–869. doi:10.1128/JCM.02367-10
- Schwebke JR, Hobbs MM, Taylor SN, et al. Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. J Clin Microbiol 2011; 49(12):4106–4111. doi:10.1128/JCM.01291-11
- College of American Pathologists. CAP surveys, Trichomonas vaginalis molecular, set TVAG-A. https://documents.cap.org/documents/2018-surveys-anatomic-pathology-ed-programs-catalog.pdf. Accessed October 31, 2019.
- Schwebke JR, Gaydos CA, Davis T, et al. Clinical evaluation of the Cepheid Xpert TV assay for detection of Trichomonas vaginalis with prospectively collected specimens from men and women. J Clin Microbiol 2018; 56(2). doi:10.1128/JCM.01091-17
- Kissinger P, Muzny CA, Mena LA, et al. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis 2018; 18(11):1251–1259. doi:10.1016/S1473-3099(18)30423-7
- Forna F, Gulmezoglu AM. Interventions for treating trichomoniasis in women. Cochrane Database Syst Rev 2003; (2):CD000218. doi:10.1002/14651858.CD000218
Sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis are still increasing in incidence and probably will continue to do so in the near future. Moreover, drug-resistant strains of Neisseria gonorrhoeae are emerging, as are less-known organisms such as Mycoplasma genitalium.
Now the good news: new tests for STIs are available or are coming! Based on nucleic acid amplification, these tests can be performed at the point of care, so that patients can leave the clinic with an accurate diagnosis and proper treatment for themselves and their sexual partners. Also, the tests can be run on samples collected by the patients themselves, either swabs or urine collections, eliminating the need for invasive sampling and making doctor-shy patients more likely to come in to be treated.1 We hope that by using these sensitive and accurate tests we can begin to bend the upward curve of STIs and be better antimicrobial stewards.2
This article reviews current issues surrounding STI control, and provides detailed guidance on recognizing, testing for, and treating gonorrhea, chlamydia, trichomoniasis, and M genitalium infection.
STI RATES ARE HIGH AND RISING
STIs are among the most common acute infectious diseases worldwide, with an estimated 1 million new curable cases every day.3 Further, STIs have major impacts on sexual, reproductive, and psychological health.
In the United States, rates of reportable STIs (chlamydia, gonorrhea, and syphilis) are rising.4 In addition, more-sensitive tests for trichomoniasis, which is not a reportable infection in any state, have revealed it to be more prevalent than previously thought.5
BARRIERS AND CHALLENGES TO DIAGNOSIS
The medical system does not fully meet the needs of some populations, including young people and men who have sex with men, regarding their sexual and reproductive health.
Ongoing barriers among young people include reluctance to use available health services, limited access to STI testing, worries about confidentiality, and the shame and stigma associated with STIs.6
Men who have sex with men have a higher incidence of STIs than other groups. Since STIs are associated with a higher risk of human immunodeficiency virus (HIV) infection, it is important to detect, diagnose, and manage STIs in this group—and in all high-risk groups. Rectal STIs are an independent risk factor for incident HIV infection.7 In addition, many men who have sex with men face challenges navigating the emotional, physical, and cognitive aspects of adolescence, a voyage further complicated by mental health issues, unprotected sexual encounters, and substance abuse in many, especially among minority youth.8 These same factors also impair their ability to access resources for preventing and treating HIV and other STIs.
STI diagnosis is often missed
Most people who have STIs feel no symptoms, which increases the importance of risk-based screening to detect these infections.9,10 In many other cases, STIs manifest with nonspecific genitourinary symptoms that are mistaken for urinary tract infection. Tomas et al11 found that of 264 women who presented to an emergency department with genitourinary symptoms or were being treated for urinary tract infection, 175 were given a diagnosis of a urinary tract infection. Of these, 100 (57%) were treated without performing a urine culture; 60 (23%) of the 264 women had 1 or more positive STI tests, 22 (37%) of whom did not receive treatment for an STI.
Poor follow-up of patients and partners
Patients with STIs need to be retested 3 months after treatment to make sure the treatment was effective. Another reason for follow-up is that these patients are at higher risk of another infection within a year.12
Although treating patients’ partners has been shown to reduce reinfection rates, fewer than one-third of STIs (including HIV infections) were recognized through partner notification between 2010 and 2012 in a Dutch study, in men who have sex with men and in women.13 Challenges included partners who could not be identified among men who have sex with men, failure of heterosexual men to notify their partners, and lower rates of partner notification for HIV.
In the United States, “expedited partner therapy” allows healthcare providers to provide a prescription or medications to partners of patients diagnosed with chlamydia or gonorrhea without examining the partner.14 While this approach is legal in most states, implementation can be challenging.15
STI EVALUATION
History and physical examination
A complete sexual history helps in estimating the patient’s risk of an STI and applying appropriate risk-based screening. Factors such as sexual practices, use of barrier protection, and history of STIs should be discussed.
Physical examination is also important. Although some patients may experience discomfort during a genital or pelvic examination, omitting this step may lead to missed diagnoses in women with STIs.16
Laboratory testing
Laboratory testing for STIs helps ensure accurate diagnosis and treatment. Empiric treatment without testing could give a patient a false sense of health by missing an infection that is not currently causing symptoms but that could later worsen or have lasting complications. Failure to test patients also misses the opportunity for partner notification, linkage to services, and follow-up testing.
Many of the most common STIs, including gonorrhea, chlamydia, and trichomoniasis, can be detected using vaginal, cervical, or urethral swabs or first-catch urine (from the initial urine stream). In studies that compared various sampling methods,17 self-collected urine samples for gonorrhea in men were nearly as good as clinician-collected swabs of the urethra. In women, self-collected vaginal swabs for gonorrhea and chlamydia were nearly as good as clinician-collected vaginal swabs. While urine specimens are acceptable for chlamydia testing in women, their sensitivity may be slightly lower than with vaginal and endocervical swab specimens.18,19
A major advantage of urine specimens for STI testing is that collection is noninvasive and is therefore more likely to be acceptable to patients. Urine testing can also be conducted in a variety of nonclinical settings such as health fairs, pharmacy-based screening programs, and express STI testing sites, thus increasing availability.
To prevent further transmission and morbidity and to aid in public health efforts, it is critical to recognize the cause of infectious cervicitis and urethritis and to screen for STIs according to guidelines.12 Table 1 summarizes current screening and laboratory testing recommendations.
GONORRHEA AND CHLAMYDIA
Gonorrhea and chlamydia are the 2 most frequently reported STIs in the United States, with more than 550,000 cases of gonorrhea and 1.7 million cases of chlamydia reported in 2017.4
Both infections present similarly: cervicitis or urethritis characterized by discharge (mucopurulent discharge with gonorrhea) and dysuria. Untreated, they can lead to pelvic inflammatory disease, inflammation, and infertility.
Extragenital infections can be asymptomatic or cause exudative pharyngitis or proctitis. Most people in whom chlamydia is detected from pharyngeal specimens are asymptomatic. When pharyngeal symptoms exist secondary to gonorrheal infection, they typically include sore throat and pharyngeal exudates. However, Komaroff et al,20 in a study of 192 men and women who presented with sore throat, found that only 2 (1%) tested positive for N gonorrhoeae.
Screening for gonorrhea and chlamydia
Best practices include screening for gonorrhea and chlamydia as follows21–23:
- Every year in sexually active women through age 25 (including during pregnancy) and in older women who have risk factors for infection12
- At least every year in men who have sex with men, at all sites of sexual contact (urethra, pharynx, rectum), along with testing for HIV and syphilis
- Every 3 to 6 months in men who have sex with men who have multiple or anonymous partners, who are sexually active and use illicit drugs, or who have partners who use illicit drugs
- Possibly every year in young men who live in high-prevalence areas or who are seen in certain clinical settings, such as STI and adolescent clinics.
Specimens. A vaginal swab is preferred for screening in women. Several studies have shown that self-collected swabs have clinical sensitivity and specificity comparable to that of provider-collected samples.17,24 First-catch urine or endocervical swabs have similar performance characteristics and are also acceptable. In men, urethral swabs or first-catch urine samples are appropriate for screening for urogenital infections.
Testing methods. Testing for both pathogens should be done simultaneously with a nucleic acid amplification test (NAAT). Commercially available NAATs are more sensitive than culture and antigen testing for detecting gonorrhea and chlamydia.25–27
Most assays are approved by the US Food and Drug Administration (FDA) for testing vaginal, urethral, cervical, and urine specimens. Until recently, no commercial assay was cleared for testing extragenital sites, but recommendations for screening extragenital sites prompted many clinical laboratories to validate throat and rectal swabs for use with NAATs, which are more sensitive than culture at these sites.25,28 The recent FDA approval of extragenital specimen types for 2 commercially available assays may increase the availability of testing for these sites.
Data on the utility of NAATs for detecting chlamydia and gonorrhea in children are limited, and many clinical laboratories have not validated molecular methods for testing in children. Current guidelines specific to this population should be followed regarding test methods and preferred specimen types.12,29,30
Although gonococcal infection is usually diagnosed with culture-independent molecular methods, antimicrobial resistance is emerging. Thus, failure of the combination of ceftriaxone and azithromycin should prompt culture-based follow-up testing to determine antimicrobial susceptibility.
Strategies for treatment and control
Historically, people treated for gonorrhea have been treated for chlamydia at the same time, as these diseases tend to go together. This can be with a single intramuscular dose of ceftriaxone for the gonorrhea plus a single oral dose of azithromycin for the chlamydia.12 For patients who have only gonorrhea, this double regimen may help prevent the development of resistant gonorrhea strains.
All the patient’s sexual partners in the previous 60 days should be tested and treated, and expedited partner therapy should be offered if possible. Patients should be advised to have no sexual contact until they complete the treatment, or 7 days after single-dose treatment. Testing should be repeated 3 months after treatment.
M GENITALIUM IS EMERGING
A member of the Mycoplasmataceae family, M genitalium was originally identified as a pathogen in the early 1980s but has only recently emerged as an important cause of STI. Studies indicate that it is responsible for 10% to 20% of cases of nongonococcal urethritis and 10% to 30% of cases of cervicitis.31–33 Additionally, 2% to 22% of cases of pelvic inflammatory disease have evidence of M genitalium.34,35
However, data on M genitalium prevalence are suspect because the organism is hard to identify—lacking a cell wall, it is undetectable by Gram stain.36 Although it has been isolated in respiratory and synovial fluids, it has so far been recognized to be clinically important only in the urogenital tract. It can persist for years in infected patients by exploiting specialized cell-surface structures to invade cells.36 Once inside a cell, it triggers secretion of mycoplasmal toxins and destructive metabolites such as hydrogen peroxide, evading the host immune system as it does so.37
Testing guidelines for M genitalium
Current guidelines do not recommend routine screening for M genitalium, and no commercial test was available until recently.12 Although evidence suggests that M genitalium is independently associated with preterm birth and miscarriages,38 routine screening of pregnant women is not recommended.12
Testing for M genitalium should be considered in cases of persistent or recurrent nongonococcal urethritis in patients who test negative for gonorrhea and chlamydia or for whom treatment has failed.12 Many isolates exhibit genotypic resistance to macrolide antibiotics, which are often the first-line therapy for nongonococcal urethritis.39
Further study is needed to evaluate the potential impact of routine screening for M genitalium on the reproductive and sexual health of at-risk populations.
Diagnostic tests for M genitalium
Awareness of M genitalium as a cause of nongonococcal urethritis has been hampered by a dearth of diagnostic tests.40 The organism’s fastidious requirements and extremely slow growth preclude culture as a practical method of diagnosis.41 Serologic assays are dogged by cross-reactivity and poor sensitivity.42,43 Thus, molecular assays for detecting M genitalium and associated resistance markers are preferred for diagnosis.12
Several molecular tests are approved, available, and in use in Europe for diagnosing M genitalium infection,40 and in January 2019 the FDA approved a molecular test that can detect M genitalium in urine specimens and vaginal, endocervical, urethral, and penile meatal swabs. Although vaginal swabs are preferred for this assay because they have higher sensitivity (92% for provider-collected and 99% for patient-collected swabs), urine specimens are acceptable, with a sensitivity of 78%.44
At least 1 company is seeking FDA clearance for another molecular diagnostic assay for detecting M genitalium and markers of macrolide resistance in urine and genital swab specimens. Such assays may facilitate appropriate treatment.
Clinicians should stay abreast of diagnostic testing options, which are likely to become more readily available soon.
A high rate of macrolide resistance
Because M genitalium lacks a cell wall, antibiotics such as beta-lactams that target cell wall synthesis are ineffective.
Regimens for treating M genitalium are outlined in Table 2.12 Azithromycin is more effective than doxycycline. However, as many as 50% of strains were macrolide-resistant in a cohort of US female patients.45 Given the high incidence of treatment failure with azithromycin 1 g, it is thought that this regimen might select for resistance. For cases in which symptoms persist, a 1- to 2-week course of moxifloxacin is recommended.12 However, this has not been validated by clinical trials, and failures of the 7-day regimen have been reported.46
Partners of patients who test positive for M genitalium should also be tested and undergo clinically applicable screening for nongonococcal urethritis, cervicitis, and pelvic inflammatory disease.12
TRICHOMONIASIS
Trichomoniasis, caused by the parasite Trichomonas vaginalis, is the most prevalent nonviral STI in the United States. It disproportionately affects black women, in whom the prevalence is 13%, compared with 1% in non-Hispanic white women.47 It is also present in 26% of women with symptoms who are seen in STI clinics and is highly prevalent in incarcerated populations. It is uncommon in men who have sex with men.48
In men, trichomoniasis manifests as urethritis, epididymitis, or prostatitis. While most infected women have no symptoms, they may experience vaginitis with discharge that is diffuse, frothy, pruritic, malodorous, or yellow-green. Vaginal and cervical erythema (“strawberry cervix”) can also occur.
Screening for trichomoniasis
Current guidelines of the US Centers for Disease Control and Prevention (CDC) recommend testing for T vaginalis in women who have symptoms and routinely screening in women who are HIV-positive, regardless of symptoms. There is no evidence to support routine screening of pregnant women without symptoms, and pregnant women who do have symptoms should be evaluated according to the same guidelines as for nonpregnant women.12 Testing can be considered in patients who have no symptoms but who engage in high-risk behaviors and in areas of high prevalence.
A lack of studies using sensitive methods for T vaginalis detection has hampered a true estimation of disease burden and at-risk populations. Screening recommendations may evolve in upcoming clinical guidelines as the field advances.
As infection can recur, women should be retested 3 months after initial diagnosis.12
NAAT is the preferred test for trichomoniasis
Commercially available diagnostic tests for trichomoniasis include culture, antigen testing, and NAAT.49 While many clinicians do their own wet-mount microscopy for a rapid result, this method has low sensitivity.50 Similarly, antigen testing and culture perform poorly compared with NAATs, which are the gold standard for detection.51,52 A major advantage of NAATs for T vaginalis detection is that they combine high sensitivity and fast results, facilitating diagnosis and appropriate treatment of patients and their partners.
In spite of these benefits, adoption of molecular diagnostic testing for T vaginalis has lagged behind that for chlamydia and gonorrhea.53 FDA-cleared NAATs are available for testing vaginal, cervical, or urine specimens from women, but until recently, there were no approved assays for testing in men. The Cepheid Xpert TV assay, which is valid for male urine specimens to diagnose other sexually transmitted diseases, has demonstrated excellent diagnostic sensitivity for T vaginalis in men and women.54 Interestingly, a large proportion of male patients in this study had no symptoms, suggesting that screening of men in high-risk groups may be warranted.
7-day metronidazole treatment beats single-dose treatment
The first-line treatment for trichomoniasis has been a single dose of metronidazole 2 g by mouth, but in a recent randomized controlled trial,55 a course of 500 mg by mouth twice a day for 7 days was 45% more effective at 4 weeks than a single dose, and it should now be the preferred regimen.
In clinical trials,56 a single dose of tinidazole 2 g orally was equivalent or superior to metronidazole 2 g and had fewer gastrointestinal side effects, but it is more expensive.
Sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis are still increasing in incidence and probably will continue to do so in the near future. Moreover, drug-resistant strains of Neisseria gonorrhoeae are emerging, as are less-known organisms such as Mycoplasma genitalium.
Now the good news: new tests for STIs are available or are coming! Based on nucleic acid amplification, these tests can be performed at the point of care, so that patients can leave the clinic with an accurate diagnosis and proper treatment for themselves and their sexual partners. Also, the tests can be run on samples collected by the patients themselves, either swabs or urine collections, eliminating the need for invasive sampling and making doctor-shy patients more likely to come in to be treated.1 We hope that by using these sensitive and accurate tests we can begin to bend the upward curve of STIs and be better antimicrobial stewards.2
This article reviews current issues surrounding STI control, and provides detailed guidance on recognizing, testing for, and treating gonorrhea, chlamydia, trichomoniasis, and M genitalium infection.
STI RATES ARE HIGH AND RISING
STIs are among the most common acute infectious diseases worldwide, with an estimated 1 million new curable cases every day.3 Further, STIs have major impacts on sexual, reproductive, and psychological health.
In the United States, rates of reportable STIs (chlamydia, gonorrhea, and syphilis) are rising.4 In addition, more-sensitive tests for trichomoniasis, which is not a reportable infection in any state, have revealed it to be more prevalent than previously thought.5
BARRIERS AND CHALLENGES TO DIAGNOSIS
The medical system does not fully meet the needs of some populations, including young people and men who have sex with men, regarding their sexual and reproductive health.
Ongoing barriers among young people include reluctance to use available health services, limited access to STI testing, worries about confidentiality, and the shame and stigma associated with STIs.6
Men who have sex with men have a higher incidence of STIs than other groups. Since STIs are associated with a higher risk of human immunodeficiency virus (HIV) infection, it is important to detect, diagnose, and manage STIs in this group—and in all high-risk groups. Rectal STIs are an independent risk factor for incident HIV infection.7 In addition, many men who have sex with men face challenges navigating the emotional, physical, and cognitive aspects of adolescence, a voyage further complicated by mental health issues, unprotected sexual encounters, and substance abuse in many, especially among minority youth.8 These same factors also impair their ability to access resources for preventing and treating HIV and other STIs.
STI diagnosis is often missed
Most people who have STIs feel no symptoms, which increases the importance of risk-based screening to detect these infections.9,10 In many other cases, STIs manifest with nonspecific genitourinary symptoms that are mistaken for urinary tract infection. Tomas et al11 found that of 264 women who presented to an emergency department with genitourinary symptoms or were being treated for urinary tract infection, 175 were given a diagnosis of a urinary tract infection. Of these, 100 (57%) were treated without performing a urine culture; 60 (23%) of the 264 women had 1 or more positive STI tests, 22 (37%) of whom did not receive treatment for an STI.
Poor follow-up of patients and partners
Patients with STIs need to be retested 3 months after treatment to make sure the treatment was effective. Another reason for follow-up is that these patients are at higher risk of another infection within a year.12
Although treating patients’ partners has been shown to reduce reinfection rates, fewer than one-third of STIs (including HIV infections) were recognized through partner notification between 2010 and 2012 in a Dutch study, in men who have sex with men and in women.13 Challenges included partners who could not be identified among men who have sex with men, failure of heterosexual men to notify their partners, and lower rates of partner notification for HIV.
In the United States, “expedited partner therapy” allows healthcare providers to provide a prescription or medications to partners of patients diagnosed with chlamydia or gonorrhea without examining the partner.14 While this approach is legal in most states, implementation can be challenging.15
STI EVALUATION
History and physical examination
A complete sexual history helps in estimating the patient’s risk of an STI and applying appropriate risk-based screening. Factors such as sexual practices, use of barrier protection, and history of STIs should be discussed.
Physical examination is also important. Although some patients may experience discomfort during a genital or pelvic examination, omitting this step may lead to missed diagnoses in women with STIs.16
Laboratory testing
Laboratory testing for STIs helps ensure accurate diagnosis and treatment. Empiric treatment without testing could give a patient a false sense of health by missing an infection that is not currently causing symptoms but that could later worsen or have lasting complications. Failure to test patients also misses the opportunity for partner notification, linkage to services, and follow-up testing.
Many of the most common STIs, including gonorrhea, chlamydia, and trichomoniasis, can be detected using vaginal, cervical, or urethral swabs or first-catch urine (from the initial urine stream). In studies that compared various sampling methods,17 self-collected urine samples for gonorrhea in men were nearly as good as clinician-collected swabs of the urethra. In women, self-collected vaginal swabs for gonorrhea and chlamydia were nearly as good as clinician-collected vaginal swabs. While urine specimens are acceptable for chlamydia testing in women, their sensitivity may be slightly lower than with vaginal and endocervical swab specimens.18,19
A major advantage of urine specimens for STI testing is that collection is noninvasive and is therefore more likely to be acceptable to patients. Urine testing can also be conducted in a variety of nonclinical settings such as health fairs, pharmacy-based screening programs, and express STI testing sites, thus increasing availability.
To prevent further transmission and morbidity and to aid in public health efforts, it is critical to recognize the cause of infectious cervicitis and urethritis and to screen for STIs according to guidelines.12 Table 1 summarizes current screening and laboratory testing recommendations.
GONORRHEA AND CHLAMYDIA
Gonorrhea and chlamydia are the 2 most frequently reported STIs in the United States, with more than 550,000 cases of gonorrhea and 1.7 million cases of chlamydia reported in 2017.4
Both infections present similarly: cervicitis or urethritis characterized by discharge (mucopurulent discharge with gonorrhea) and dysuria. Untreated, they can lead to pelvic inflammatory disease, inflammation, and infertility.
Extragenital infections can be asymptomatic or cause exudative pharyngitis or proctitis. Most people in whom chlamydia is detected from pharyngeal specimens are asymptomatic. When pharyngeal symptoms exist secondary to gonorrheal infection, they typically include sore throat and pharyngeal exudates. However, Komaroff et al,20 in a study of 192 men and women who presented with sore throat, found that only 2 (1%) tested positive for N gonorrhoeae.
Screening for gonorrhea and chlamydia
Best practices include screening for gonorrhea and chlamydia as follows21–23:
- Every year in sexually active women through age 25 (including during pregnancy) and in older women who have risk factors for infection12
- At least every year in men who have sex with men, at all sites of sexual contact (urethra, pharynx, rectum), along with testing for HIV and syphilis
- Every 3 to 6 months in men who have sex with men who have multiple or anonymous partners, who are sexually active and use illicit drugs, or who have partners who use illicit drugs
- Possibly every year in young men who live in high-prevalence areas or who are seen in certain clinical settings, such as STI and adolescent clinics.
Specimens. A vaginal swab is preferred for screening in women. Several studies have shown that self-collected swabs have clinical sensitivity and specificity comparable to that of provider-collected samples.17,24 First-catch urine or endocervical swabs have similar performance characteristics and are also acceptable. In men, urethral swabs or first-catch urine samples are appropriate for screening for urogenital infections.
Testing methods. Testing for both pathogens should be done simultaneously with a nucleic acid amplification test (NAAT). Commercially available NAATs are more sensitive than culture and antigen testing for detecting gonorrhea and chlamydia.25–27
Most assays are approved by the US Food and Drug Administration (FDA) for testing vaginal, urethral, cervical, and urine specimens. Until recently, no commercial assay was cleared for testing extragenital sites, but recommendations for screening extragenital sites prompted many clinical laboratories to validate throat and rectal swabs for use with NAATs, which are more sensitive than culture at these sites.25,28 The recent FDA approval of extragenital specimen types for 2 commercially available assays may increase the availability of testing for these sites.
Data on the utility of NAATs for detecting chlamydia and gonorrhea in children are limited, and many clinical laboratories have not validated molecular methods for testing in children. Current guidelines specific to this population should be followed regarding test methods and preferred specimen types.12,29,30
Although gonococcal infection is usually diagnosed with culture-independent molecular methods, antimicrobial resistance is emerging. Thus, failure of the combination of ceftriaxone and azithromycin should prompt culture-based follow-up testing to determine antimicrobial susceptibility.
Strategies for treatment and control
Historically, people treated for gonorrhea have been treated for chlamydia at the same time, as these diseases tend to go together. This can be with a single intramuscular dose of ceftriaxone for the gonorrhea plus a single oral dose of azithromycin for the chlamydia.12 For patients who have only gonorrhea, this double regimen may help prevent the development of resistant gonorrhea strains.
All the patient’s sexual partners in the previous 60 days should be tested and treated, and expedited partner therapy should be offered if possible. Patients should be advised to have no sexual contact until they complete the treatment, or 7 days after single-dose treatment. Testing should be repeated 3 months after treatment.
M GENITALIUM IS EMERGING
A member of the Mycoplasmataceae family, M genitalium was originally identified as a pathogen in the early 1980s but has only recently emerged as an important cause of STI. Studies indicate that it is responsible for 10% to 20% of cases of nongonococcal urethritis and 10% to 30% of cases of cervicitis.31–33 Additionally, 2% to 22% of cases of pelvic inflammatory disease have evidence of M genitalium.34,35
However, data on M genitalium prevalence are suspect because the organism is hard to identify—lacking a cell wall, it is undetectable by Gram stain.36 Although it has been isolated in respiratory and synovial fluids, it has so far been recognized to be clinically important only in the urogenital tract. It can persist for years in infected patients by exploiting specialized cell-surface structures to invade cells.36 Once inside a cell, it triggers secretion of mycoplasmal toxins and destructive metabolites such as hydrogen peroxide, evading the host immune system as it does so.37
Testing guidelines for M genitalium
Current guidelines do not recommend routine screening for M genitalium, and no commercial test was available until recently.12 Although evidence suggests that M genitalium is independently associated with preterm birth and miscarriages,38 routine screening of pregnant women is not recommended.12
Testing for M genitalium should be considered in cases of persistent or recurrent nongonococcal urethritis in patients who test negative for gonorrhea and chlamydia or for whom treatment has failed.12 Many isolates exhibit genotypic resistance to macrolide antibiotics, which are often the first-line therapy for nongonococcal urethritis.39
Further study is needed to evaluate the potential impact of routine screening for M genitalium on the reproductive and sexual health of at-risk populations.
Diagnostic tests for M genitalium
Awareness of M genitalium as a cause of nongonococcal urethritis has been hampered by a dearth of diagnostic tests.40 The organism’s fastidious requirements and extremely slow growth preclude culture as a practical method of diagnosis.41 Serologic assays are dogged by cross-reactivity and poor sensitivity.42,43 Thus, molecular assays for detecting M genitalium and associated resistance markers are preferred for diagnosis.12
Several molecular tests are approved, available, and in use in Europe for diagnosing M genitalium infection,40 and in January 2019 the FDA approved a molecular test that can detect M genitalium in urine specimens and vaginal, endocervical, urethral, and penile meatal swabs. Although vaginal swabs are preferred for this assay because they have higher sensitivity (92% for provider-collected and 99% for patient-collected swabs), urine specimens are acceptable, with a sensitivity of 78%.44
At least 1 company is seeking FDA clearance for another molecular diagnostic assay for detecting M genitalium and markers of macrolide resistance in urine and genital swab specimens. Such assays may facilitate appropriate treatment.
Clinicians should stay abreast of diagnostic testing options, which are likely to become more readily available soon.
A high rate of macrolide resistance
Because M genitalium lacks a cell wall, antibiotics such as beta-lactams that target cell wall synthesis are ineffective.
Regimens for treating M genitalium are outlined in Table 2.12 Azithromycin is more effective than doxycycline. However, as many as 50% of strains were macrolide-resistant in a cohort of US female patients.45 Given the high incidence of treatment failure with azithromycin 1 g, it is thought that this regimen might select for resistance. For cases in which symptoms persist, a 1- to 2-week course of moxifloxacin is recommended.12 However, this has not been validated by clinical trials, and failures of the 7-day regimen have been reported.46
Partners of patients who test positive for M genitalium should also be tested and undergo clinically applicable screening for nongonococcal urethritis, cervicitis, and pelvic inflammatory disease.12
TRICHOMONIASIS
Trichomoniasis, caused by the parasite Trichomonas vaginalis, is the most prevalent nonviral STI in the United States. It disproportionately affects black women, in whom the prevalence is 13%, compared with 1% in non-Hispanic white women.47 It is also present in 26% of women with symptoms who are seen in STI clinics and is highly prevalent in incarcerated populations. It is uncommon in men who have sex with men.48
In men, trichomoniasis manifests as urethritis, epididymitis, or prostatitis. While most infected women have no symptoms, they may experience vaginitis with discharge that is diffuse, frothy, pruritic, malodorous, or yellow-green. Vaginal and cervical erythema (“strawberry cervix”) can also occur.
Screening for trichomoniasis
Current guidelines of the US Centers for Disease Control and Prevention (CDC) recommend testing for T vaginalis in women who have symptoms and routinely screening in women who are HIV-positive, regardless of symptoms. There is no evidence to support routine screening of pregnant women without symptoms, and pregnant women who do have symptoms should be evaluated according to the same guidelines as for nonpregnant women.12 Testing can be considered in patients who have no symptoms but who engage in high-risk behaviors and in areas of high prevalence.
A lack of studies using sensitive methods for T vaginalis detection has hampered a true estimation of disease burden and at-risk populations. Screening recommendations may evolve in upcoming clinical guidelines as the field advances.
As infection can recur, women should be retested 3 months after initial diagnosis.12
NAAT is the preferred test for trichomoniasis
Commercially available diagnostic tests for trichomoniasis include culture, antigen testing, and NAAT.49 While many clinicians do their own wet-mount microscopy for a rapid result, this method has low sensitivity.50 Similarly, antigen testing and culture perform poorly compared with NAATs, which are the gold standard for detection.51,52 A major advantage of NAATs for T vaginalis detection is that they combine high sensitivity and fast results, facilitating diagnosis and appropriate treatment of patients and their partners.
In spite of these benefits, adoption of molecular diagnostic testing for T vaginalis has lagged behind that for chlamydia and gonorrhea.53 FDA-cleared NAATs are available for testing vaginal, cervical, or urine specimens from women, but until recently, there were no approved assays for testing in men. The Cepheid Xpert TV assay, which is valid for male urine specimens to diagnose other sexually transmitted diseases, has demonstrated excellent diagnostic sensitivity for T vaginalis in men and women.54 Interestingly, a large proportion of male patients in this study had no symptoms, suggesting that screening of men in high-risk groups may be warranted.
7-day metronidazole treatment beats single-dose treatment
The first-line treatment for trichomoniasis has been a single dose of metronidazole 2 g by mouth, but in a recent randomized controlled trial,55 a course of 500 mg by mouth twice a day for 7 days was 45% more effective at 4 weeks than a single dose, and it should now be the preferred regimen.
In clinical trials,56 a single dose of tinidazole 2 g orally was equivalent or superior to metronidazole 2 g and had fewer gastrointestinal side effects, but it is more expensive.
- Harding-Esch EM, Nori AV, Hegazi A, et al. Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation. Sex Transm Infect 2017; 93(6):424–429. doi:10.1136/sextrans-2016-052988
- Unemo M, Bradshaw CS, Hocking JS, et al. Sexually transmitted infections: challenges ahead. Lancet Infect Dis 2017; 17(8):e235–e279. doi:10.1016/S1473-3099(17)30310-9
- Newman L, Rowley J, Vander Hoorn S, et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One 2015; 10(12):e0143304. doi:10.1371/journal.pone.0143304
- Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2017. www.cdc.gov/std/stats17/toc.htm. Accessed October 7, 2019.
- Ginocchio CC, Chapin K, Smith JS, et al. Prevalence of Trichomonas vaginalis and coinfection with Chlamydia trachomatis and Neisseria gonorrhoeae in the United States as determined by the Aptima Trichomonas vaginalis nucleic acid amplification assay. J Clin Microbiol 2012; 50(8):2601–2608. doi:10.1128/JCM.00748-12
- Newton-Levinson A, Leichliter JS, Chandra-Mouli V. Sexually transmitted infection services for adolescents and youth in low- and middle-income countries: perceived and experienced barriers to accessing care. J Adolesc Health 2016; 59(1):7–16.
doi:10.1016/j.jadohealth.2016.03.014 - Barbee LA, Khosropour CM, Dombrowksi JC, Golden MR. New human immunodeficiency virus diagnosis independently associated with rectal gonorrhea and chlamydia in men who have sex with men. Sex Transm Dis 2017; 44(7):385–389. doi:10.1097/OLQ.0000000000000614
- Halkitis PN, Kapadia F, Bub KL, Barton S, Moreira AD, Stults CB. A longitudinal investigation of syndemic conditions among young gay, bisexual, and other MSM: the P18 cohort study. AIDS Behav 2015; 19(6):970–980. doi:10.1007/s10461-014-0892-y
- Farley TA, Cohen DA, Elkins W. Asymptomatic sexually transmitted diseases: the case for screening. Prev Med 2003; 36(4):502–509. pmid:12649059
- Patel P, Bush T, Mayer K, et al; SUN Study Investigators. Routine brief risk-reduction counseling with biannual STD testing reduces STD incidence among HIV-infected men who have sex with men in care. Sex Transm Dis 2012; 39(6):470–474. doi:10.1097/OLQ.0b013e31824b3110
- Tomas ME, Getman D, Donskey CJ, Hecker MT. Overdiagnosis of urinary tract infection and underdiagnosis of sexually transmitted infection in adult women presenting to an emergency department. J Clin Microbiol 2015; 53(8):2686–2692. doi:10.1128/JCM.00670-15
- Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64(RR–03): 1–137. pmid:26042815
- van Aar F, van Weert Y, Spijker R, Gotz H, Op de Coul E; Partner Notification Group. Partner notification among men who have sex with men and heterosexuals with STI/HIV: different outcomes and challenges. Int J STD AIDS 2015; 26(8):565–573. doi:10.1177/0956462414547398
- Centers for Disease Control and Prevention. Sexually transmitted diseases (STDa): expedited partner therapy. www.cdc.gov/std/ept/. Accessed October 7, 2019.
- Jamison CD, Chang T, Mmeje O. Expedited partner therapy: combating record high sexually transmitted infection rates. Am J Public Health 2018; 108(10):1325–1327. doi:10.2105/AJPH.2018.304570
- Singh RH, Zenilman JM, Brown KM, Madden T, Gaydos C, Ghanem KG. The role of physical examination in diagnosing common causes of vaginitis: a prospective study. Sex Transm Infect 2013; 89(3):185–190. doi:10.1136/sextrans-2012-050550
- Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One 2015; 10(7):e0132776. doi:10.1371/journal.pone.0132776
- Michel CE, Sonnex C, Carne CA, et al. Chlamydia trachomatis load at matched anatomic sites: implications for screening strategies. J Clin Microbiol 2007; 45(5):1395–1402. doi:10.1128/JCM.00100-07
- Schachter J, Chernesky MA, Willis DE, et al. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis 2005; 32(12):725–728. pmid:16314767
- Komaroff AL, Aronson MD, Pass TM, Ervin CT. Prevalence of pharyngeal gonorrhea in general medical patients with sore throats. Sex Transm Dis 1980; 7(3):116–119. pmid:6777884
- Centers for Disease Control and Prevention. Clinic-based testing for rectal and pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections by community-based organizations—five cities, United States, 2007. MMWR Morb Mortal Wkly Rep 2009; 58(26):716–719. pmid:19590491
- Chesson HW, Bernstein KT, Gift TL, Marcus JL, Pipkin S, Kent CK. The cost-effectiveness of screening men who have sex with men for rectal chlamydial and gonococcal infection to prevent HIV Infection. Sex Transm Dis 2013; 40(5):366–471. doi:10.1097/OLQ.0b013e318284e544
- Park J, Marcus JL, Pandori M, Snell A, Philip SS, Bernstein KT. Sentinel surveillance for pharyngeal chlamydia and gonorrhea among men who have sex with men—San Francisco, 2010. Sex Transm Dis 2012; 39(6):482–484. doi:10.1097/OLQ.0b013e3182495e2f
- Masek BJ, Arora N, Quinn N, et al. Performance of three nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of self-collected vaginal swabs obtained via an internet-based screening program. J Clin Microbiol 2009; 47(6):1663–1667. doi:10.1128/JCM.02387-08
- Bachmann LH, Johnson RE, Cheng H, et al. Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. J Clin Microbiol 2010; 48(5):1827–1832. doi:10.1128/JCM.02398-09
- Mimiaga MJ, Mayer KH, Reisner SL, et al. Asymptomatic gonorrhea and chlamydial infections detected by nucleic acid amplification tests among Boston area men who have sex with men. Sex Transm Dis 2008; 35(5):495–498. doi:10.1097/OLQ.0b013e31816471ae
- Schachter J, Moncada J, Liska S, Shayevich C, Klausner JD. Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis 2008; 35(7):637–642. doi:10.1097/OLQ.0b013e31817bdd7e
- Cornelisse VJ, Chow EP, Huffam S, et al. Increased detection of pharyngeal and rectal gonorrhea in men who have sex with men after transition from culture to nucleic acid amplification testing. Sex Transm Dis 2017; 44(2):114–117. doi:10.1097/OLQ.0000000000000553
- Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae—2014. MMWR Recomm Rep 2014; 63(RR–02):1–19. pmid:24622331
- Hammerschlag MR, Gaydos CA. Guidelines for the use of molecular biological methods to detect sexually transmitted pathogens in cases of suspected sexual abuse in children. Methods Mol Biol 2012; 903:307–317. doi:10.1007/978-1-61779-937-2_21
- Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Hobbs MM. Mycoplasma genitalium detected by transcription-mediated amplification is associated with Chlamydia trachomatis in adolescent women. Sex Transm Dis 2008; 35(3):250–254. doi:10.1097/OLQ.0b013e31815abac6
- Pond MJ, Nori AV, Witney AA, Lopeman RC, Butcher PD, Sadiq ST. High prevalence of antibiotic-resistant Mycoplasma genitalium in nongonococcal urethritis: the need for routine testing and the inadequacy of current treatment options. Clin Infect Dis 2014; 58(5):631–637. doi:10.1093/cid/cit752
- Seña AC, Lee JY, Schwebke J, et al. A silent epidemic: the prevalence, incidence and persistence of Mycoplasma genitalium among young, asymptomatic high-risk women in the United States. Clin Infect Dis 2018; 67(1):73–79. doi:10.1093/cid/ciy025
- Bjartling C, Osser S, Persson K. The association between Mycoplasma genitalium and pelvic inflammatory disease after termination of pregnancy. BJOG 2010; 117(3):361–364. doi:10.1111/j.1471-0528.2009.02455.x
- Cohen CR, Manhart LE, Bukusi EA, et al. Association between Mycoplasma genitalium and acute endometritis. Lancet 2002; 359(9308):765–766. doi:10.1016/S0140-6736(02)07848-0
- Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Microbiol Rev 2011; 24(3):498–514. doi:10.1128/CMR.00006-11
- Ross JD, Jensen JS. Mycoplasma genitalium as a sexually transmitted infection: implications for screening, testing, and treatment. Sex Transm Infect 2006; 82(4):269–271. doi:10.1136/sti.2005.017368
- Donders GG, Ruban K, Bellen G, Petricevic L. Mycoplasma/ureaplasma infection in pregnancy: to screen or not to screen. J Perinat Med 2017; 45(5):505–515. doi:10.1515/jpm-2016-0111
- Allan-Blitz LT, Mokany E, Miller S, Wee R, Shannon C, Klausner JD. Prevalence of Mycoplasma genitalium and azithromycin-resistant infections among remnant clinical specimens, Los Angeles. Sex Transm Dis 2018; 45(9):632–635. doi:10.1097/OLQ.0000000000000829
- Munson E. Molecular diagnostics update for the emerging (if not already widespread) sexually transmitted infection agent Mycoplasma genitalium: just about ready for prime time. J Clin Microbio. 2017; 55(10):2894–2902. doi:10.1128/JCM.00818-17
- Waites KB, Taylor-Robinson D. Mycoplasma and ureaplasma. In: Jorgensen JH, Pfaller MA, Carroll KC, American Society for Microbiology, eds. Manual of Clinical Microbiology. 11th ed. Washington, DC: ASM Press; 2015:1088–1105.
- Cimolai N, Bryan LE, To M, Woods DE. Immunological cross-reactivity of a Mycoplasma pneumoniae membrane-associated protein antigen with Mycoplasma genitalium and Acholeplasma laidlawii. J Clin Microbiol 1987; 25(11):2136–2139. pmid:2447119
- Ma L, Mancuso M, Williams JA, et al. Extensive variation and rapid shift of the MG192 sequence in Mycoplasma genitalium strains from patients with chronic infection. Infect Immun 2014; 82(3):1326–1334. doi:10.1128/IAI.01526-13
- Hologic. Aptima Mycoplasma genitalium assay.www.hologic.com/sites/default/files/package-insert/AW-14170-001_005_01.pdf. Accessed October 7, 2019.
- Getman D, Jiang A, O’Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 2016; 54(9):2278–2283. doi:10.1128/JCM.01053-16
- Li Y, Le WJ, Li S, Cao YP, Su XH. Meta-analysis of the efficacy of moxifloxacin in treating Mycoplasma genitalium infection. Int J STD AIDS 2017; 28(11):1106–1114. doi:10.1177/0956462416688562
- Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S, Markowitz L. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001–2004. Clin Infect Dis 2007; 45(10):1319–1326. doi:10.1086/522532
- Kelley CF, Rosenberg ES, O’Hara BM, Sanchez T, del Rio C, Sullivan PS. Prevalence of urethral Trichomonas vaginalis in black and white men who have sex with men. Sex Transm Dis 2012; 39(9):739. doi:10.1097/OLQ.0b013e318264248b
- Van Der Pol B. Clinical and laboratory testing for T vaginalis infection. J Clin Microbiol 2016; 54(1):7–12. doi:10.1128/JCM.02025-15
- Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009; 200(2):188.e1–e7. doi:10.1016/j.ajog.2008.10.005
- Andrea SB, Chapin KC. Comparison of Aptima Trichomonas vaginalis transcription-mediated amplification assay and BD affirm VPIII for detection of T. vaginalis in symptomatic women: performance parameters and epidemiological implications. J Clin Microbiol 2011; 49(3):866–869. doi:10.1128/JCM.02367-10
- Schwebke JR, Hobbs MM, Taylor SN, et al. Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. J Clin Microbiol 2011; 49(12):4106–4111. doi:10.1128/JCM.01291-11
- College of American Pathologists. CAP surveys, Trichomonas vaginalis molecular, set TVAG-A. https://documents.cap.org/documents/2018-surveys-anatomic-pathology-ed-programs-catalog.pdf. Accessed October 31, 2019.
- Schwebke JR, Gaydos CA, Davis T, et al. Clinical evaluation of the Cepheid Xpert TV assay for detection of Trichomonas vaginalis with prospectively collected specimens from men and women. J Clin Microbiol 2018; 56(2). doi:10.1128/JCM.01091-17
- Kissinger P, Muzny CA, Mena LA, et al. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis 2018; 18(11):1251–1259. doi:10.1016/S1473-3099(18)30423-7
- Forna F, Gulmezoglu AM. Interventions for treating trichomoniasis in women. Cochrane Database Syst Rev 2003; (2):CD000218. doi:10.1002/14651858.CD000218
- Harding-Esch EM, Nori AV, Hegazi A, et al. Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation. Sex Transm Infect 2017; 93(6):424–429. doi:10.1136/sextrans-2016-052988
- Unemo M, Bradshaw CS, Hocking JS, et al. Sexually transmitted infections: challenges ahead. Lancet Infect Dis 2017; 17(8):e235–e279. doi:10.1016/S1473-3099(17)30310-9
- Newman L, Rowley J, Vander Hoorn S, et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One 2015; 10(12):e0143304. doi:10.1371/journal.pone.0143304
- Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2017. www.cdc.gov/std/stats17/toc.htm. Accessed October 7, 2019.
- Ginocchio CC, Chapin K, Smith JS, et al. Prevalence of Trichomonas vaginalis and coinfection with Chlamydia trachomatis and Neisseria gonorrhoeae in the United States as determined by the Aptima Trichomonas vaginalis nucleic acid amplification assay. J Clin Microbiol 2012; 50(8):2601–2608. doi:10.1128/JCM.00748-12
- Newton-Levinson A, Leichliter JS, Chandra-Mouli V. Sexually transmitted infection services for adolescents and youth in low- and middle-income countries: perceived and experienced barriers to accessing care. J Adolesc Health 2016; 59(1):7–16.
doi:10.1016/j.jadohealth.2016.03.014 - Barbee LA, Khosropour CM, Dombrowksi JC, Golden MR. New human immunodeficiency virus diagnosis independently associated with rectal gonorrhea and chlamydia in men who have sex with men. Sex Transm Dis 2017; 44(7):385–389. doi:10.1097/OLQ.0000000000000614
- Halkitis PN, Kapadia F, Bub KL, Barton S, Moreira AD, Stults CB. A longitudinal investigation of syndemic conditions among young gay, bisexual, and other MSM: the P18 cohort study. AIDS Behav 2015; 19(6):970–980. doi:10.1007/s10461-014-0892-y
- Farley TA, Cohen DA, Elkins W. Asymptomatic sexually transmitted diseases: the case for screening. Prev Med 2003; 36(4):502–509. pmid:12649059
- Patel P, Bush T, Mayer K, et al; SUN Study Investigators. Routine brief risk-reduction counseling with biannual STD testing reduces STD incidence among HIV-infected men who have sex with men in care. Sex Transm Dis 2012; 39(6):470–474. doi:10.1097/OLQ.0b013e31824b3110
- Tomas ME, Getman D, Donskey CJ, Hecker MT. Overdiagnosis of urinary tract infection and underdiagnosis of sexually transmitted infection in adult women presenting to an emergency department. J Clin Microbiol 2015; 53(8):2686–2692. doi:10.1128/JCM.00670-15
- Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64(RR–03): 1–137. pmid:26042815
- van Aar F, van Weert Y, Spijker R, Gotz H, Op de Coul E; Partner Notification Group. Partner notification among men who have sex with men and heterosexuals with STI/HIV: different outcomes and challenges. Int J STD AIDS 2015; 26(8):565–573. doi:10.1177/0956462414547398
- Centers for Disease Control and Prevention. Sexually transmitted diseases (STDa): expedited partner therapy. www.cdc.gov/std/ept/. Accessed October 7, 2019.
- Jamison CD, Chang T, Mmeje O. Expedited partner therapy: combating record high sexually transmitted infection rates. Am J Public Health 2018; 108(10):1325–1327. doi:10.2105/AJPH.2018.304570
- Singh RH, Zenilman JM, Brown KM, Madden T, Gaydos C, Ghanem KG. The role of physical examination in diagnosing common causes of vaginitis: a prospective study. Sex Transm Infect 2013; 89(3):185–190. doi:10.1136/sextrans-2012-050550
- Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One 2015; 10(7):e0132776. doi:10.1371/journal.pone.0132776
- Michel CE, Sonnex C, Carne CA, et al. Chlamydia trachomatis load at matched anatomic sites: implications for screening strategies. J Clin Microbiol 2007; 45(5):1395–1402. doi:10.1128/JCM.00100-07
- Schachter J, Chernesky MA, Willis DE, et al. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis 2005; 32(12):725–728. pmid:16314767
- Komaroff AL, Aronson MD, Pass TM, Ervin CT. Prevalence of pharyngeal gonorrhea in general medical patients with sore throats. Sex Transm Dis 1980; 7(3):116–119. pmid:6777884
- Centers for Disease Control and Prevention. Clinic-based testing for rectal and pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections by community-based organizations—five cities, United States, 2007. MMWR Morb Mortal Wkly Rep 2009; 58(26):716–719. pmid:19590491
- Chesson HW, Bernstein KT, Gift TL, Marcus JL, Pipkin S, Kent CK. The cost-effectiveness of screening men who have sex with men for rectal chlamydial and gonococcal infection to prevent HIV Infection. Sex Transm Dis 2013; 40(5):366–471. doi:10.1097/OLQ.0b013e318284e544
- Park J, Marcus JL, Pandori M, Snell A, Philip SS, Bernstein KT. Sentinel surveillance for pharyngeal chlamydia and gonorrhea among men who have sex with men—San Francisco, 2010. Sex Transm Dis 2012; 39(6):482–484. doi:10.1097/OLQ.0b013e3182495e2f
- Masek BJ, Arora N, Quinn N, et al. Performance of three nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of self-collected vaginal swabs obtained via an internet-based screening program. J Clin Microbiol 2009; 47(6):1663–1667. doi:10.1128/JCM.02387-08
- Bachmann LH, Johnson RE, Cheng H, et al. Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. J Clin Microbiol 2010; 48(5):1827–1832. doi:10.1128/JCM.02398-09
- Mimiaga MJ, Mayer KH, Reisner SL, et al. Asymptomatic gonorrhea and chlamydial infections detected by nucleic acid amplification tests among Boston area men who have sex with men. Sex Transm Dis 2008; 35(5):495–498. doi:10.1097/OLQ.0b013e31816471ae
- Schachter J, Moncada J, Liska S, Shayevich C, Klausner JD. Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis 2008; 35(7):637–642. doi:10.1097/OLQ.0b013e31817bdd7e
- Cornelisse VJ, Chow EP, Huffam S, et al. Increased detection of pharyngeal and rectal gonorrhea in men who have sex with men after transition from culture to nucleic acid amplification testing. Sex Transm Dis 2017; 44(2):114–117. doi:10.1097/OLQ.0000000000000553
- Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae—2014. MMWR Recomm Rep 2014; 63(RR–02):1–19. pmid:24622331
- Hammerschlag MR, Gaydos CA. Guidelines for the use of molecular biological methods to detect sexually transmitted pathogens in cases of suspected sexual abuse in children. Methods Mol Biol 2012; 903:307–317. doi:10.1007/978-1-61779-937-2_21
- Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Hobbs MM. Mycoplasma genitalium detected by transcription-mediated amplification is associated with Chlamydia trachomatis in adolescent women. Sex Transm Dis 2008; 35(3):250–254. doi:10.1097/OLQ.0b013e31815abac6
- Pond MJ, Nori AV, Witney AA, Lopeman RC, Butcher PD, Sadiq ST. High prevalence of antibiotic-resistant Mycoplasma genitalium in nongonococcal urethritis: the need for routine testing and the inadequacy of current treatment options. Clin Infect Dis 2014; 58(5):631–637. doi:10.1093/cid/cit752
- Seña AC, Lee JY, Schwebke J, et al. A silent epidemic: the prevalence, incidence and persistence of Mycoplasma genitalium among young, asymptomatic high-risk women in the United States. Clin Infect Dis 2018; 67(1):73–79. doi:10.1093/cid/ciy025
- Bjartling C, Osser S, Persson K. The association between Mycoplasma genitalium and pelvic inflammatory disease after termination of pregnancy. BJOG 2010; 117(3):361–364. doi:10.1111/j.1471-0528.2009.02455.x
- Cohen CR, Manhart LE, Bukusi EA, et al. Association between Mycoplasma genitalium and acute endometritis. Lancet 2002; 359(9308):765–766. doi:10.1016/S0140-6736(02)07848-0
- Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Microbiol Rev 2011; 24(3):498–514. doi:10.1128/CMR.00006-11
- Ross JD, Jensen JS. Mycoplasma genitalium as a sexually transmitted infection: implications for screening, testing, and treatment. Sex Transm Infect 2006; 82(4):269–271. doi:10.1136/sti.2005.017368
- Donders GG, Ruban K, Bellen G, Petricevic L. Mycoplasma/ureaplasma infection in pregnancy: to screen or not to screen. J Perinat Med 2017; 45(5):505–515. doi:10.1515/jpm-2016-0111
- Allan-Blitz LT, Mokany E, Miller S, Wee R, Shannon C, Klausner JD. Prevalence of Mycoplasma genitalium and azithromycin-resistant infections among remnant clinical specimens, Los Angeles. Sex Transm Dis 2018; 45(9):632–635. doi:10.1097/OLQ.0000000000000829
- Munson E. Molecular diagnostics update for the emerging (if not already widespread) sexually transmitted infection agent Mycoplasma genitalium: just about ready for prime time. J Clin Microbio. 2017; 55(10):2894–2902. doi:10.1128/JCM.00818-17
- Waites KB, Taylor-Robinson D. Mycoplasma and ureaplasma. In: Jorgensen JH, Pfaller MA, Carroll KC, American Society for Microbiology, eds. Manual of Clinical Microbiology. 11th ed. Washington, DC: ASM Press; 2015:1088–1105.
- Cimolai N, Bryan LE, To M, Woods DE. Immunological cross-reactivity of a Mycoplasma pneumoniae membrane-associated protein antigen with Mycoplasma genitalium and Acholeplasma laidlawii. J Clin Microbiol 1987; 25(11):2136–2139. pmid:2447119
- Ma L, Mancuso M, Williams JA, et al. Extensive variation and rapid shift of the MG192 sequence in Mycoplasma genitalium strains from patients with chronic infection. Infect Immun 2014; 82(3):1326–1334. doi:10.1128/IAI.01526-13
- Hologic. Aptima Mycoplasma genitalium assay.www.hologic.com/sites/default/files/package-insert/AW-14170-001_005_01.pdf. Accessed October 7, 2019.
- Getman D, Jiang A, O’Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 2016; 54(9):2278–2283. doi:10.1128/JCM.01053-16
- Li Y, Le WJ, Li S, Cao YP, Su XH. Meta-analysis of the efficacy of moxifloxacin in treating Mycoplasma genitalium infection. Int J STD AIDS 2017; 28(11):1106–1114. doi:10.1177/0956462416688562
- Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S, Markowitz L. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001–2004. Clin Infect Dis 2007; 45(10):1319–1326. doi:10.1086/522532
- Kelley CF, Rosenberg ES, O’Hara BM, Sanchez T, del Rio C, Sullivan PS. Prevalence of urethral Trichomonas vaginalis in black and white men who have sex with men. Sex Transm Dis 2012; 39(9):739. doi:10.1097/OLQ.0b013e318264248b
- Van Der Pol B. Clinical and laboratory testing for T vaginalis infection. J Clin Microbiol 2016; 54(1):7–12. doi:10.1128/JCM.02025-15
- Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009; 200(2):188.e1–e7. doi:10.1016/j.ajog.2008.10.005
- Andrea SB, Chapin KC. Comparison of Aptima Trichomonas vaginalis transcription-mediated amplification assay and BD affirm VPIII for detection of T. vaginalis in symptomatic women: performance parameters and epidemiological implications. J Clin Microbiol 2011; 49(3):866–869. doi:10.1128/JCM.02367-10
- Schwebke JR, Hobbs MM, Taylor SN, et al. Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. J Clin Microbiol 2011; 49(12):4106–4111. doi:10.1128/JCM.01291-11
- College of American Pathologists. CAP surveys, Trichomonas vaginalis molecular, set TVAG-A. https://documents.cap.org/documents/2018-surveys-anatomic-pathology-ed-programs-catalog.pdf. Accessed October 31, 2019.
- Schwebke JR, Gaydos CA, Davis T, et al. Clinical evaluation of the Cepheid Xpert TV assay for detection of Trichomonas vaginalis with prospectively collected specimens from men and women. J Clin Microbiol 2018; 56(2). doi:10.1128/JCM.01091-17
- Kissinger P, Muzny CA, Mena LA, et al. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis 2018; 18(11):1251–1259. doi:10.1016/S1473-3099(18)30423-7
- Forna F, Gulmezoglu AM. Interventions for treating trichomoniasis in women. Cochrane Database Syst Rev 2003; (2):CD000218. doi:10.1002/14651858.CD000218
KEY POINTS
- Screen for gonorrhea and chlamydia annually—and more frequently for those at highest risk—in sexually active women age 25 and younger and in men who have sex with men, who should also be screened at the same time for human immunodeficiency virus (HIV) and syphilis.
- Test for Trichomonas vaginalis in women who have symptoms suggesting it, and routinely screen for this pathogen in women who are HIV-positive.
- Nucleic acid amplification is the preferred test for gonorrhea, chlamydia, trichomoniasis, and M genitalium infection; the use of urine specimens is acceptable.
- Consider M genitalium if therapy for gonorrhea and chlamydia fails or tests for those diseases are negative.
- Single-dose antibiotic therapy is preferred for chlamydia and uncomplicated gonorrhea. It is also available for trichomoniasis, although metronidazole 500 mg twice a day for 7 days has a higher cure rate.
SEEDS for success: Lifestyle management in migraine
Migraine is the second leading cause of years of life lived with a disability globally.1 It affects people of all ages, but particularly during the years associated with the highest productivity in terms of work and family life.
Migraine is a genetic neurologic disease that can be influenced or triggered by environmental factors. However, triggers do not cause migraine. For example, stress does not cause migraine, but it can exacerbate it.
Primary care physicians can help patients reduce the likelihood of a migraine attack, the severity of symptoms, or both by offering lifestyle counseling centered around the mnemonic SEEDS: sleep, exercise, eat, diary, and stress. In this article, each factor is discussed individually for its current support in the literature along with best-practice recommendations.
S IS FOR SLEEP
Before optimizing sleep hygiene, screen for sleep apnea, especially in those who have chronic daily headache upon awakening. An excellent tool is the STOP-Bang screening questionnaire5 (www.stopbang.ca/osa/screening.php). Patients respond “yes” or “no” to the following questions:
- Snoring: Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?
- Tired: Do you often feel tired, fatigued, or sleepy during the daytime?
- Observed: Has anyone observed you stop breathing during your sleep?
- Pressure: Do you have or are you being treated for high blood pressure?
- Body mass index greater than 35 kg/m2?
- Age over 50?
- Neck circumference larger than 40 cm (females) or 42 cm (males)?
- Gender—male?
Each “yes” answer is scored as 1 point. A score less than 3 indicates low risk of obstructive sleep apnea; 3 to 4 indicates moderate risk; and 5 or more indicates high risk. Optimization of sleep apnea with continuous positive airway pressure therapy can improve sleep apnea headache.6 The improved sleep from reduced arousals may also mitigate migraine symptoms.
Behavioral modification for sleep hygiene can convert chronic migraine to episodic migraine.7 One such program is stimulus control therapy, which focuses on using cues to initiate sleep (Table 1). Patients are encouraged to keep the bedroom quiet, dark, and cool, and to go to sleep at the same time every night. Importantly, the bed should be associated only with sleep. If patients are unable to fall asleep within 20 to 30 minutes, they should leave the room so they do not associate the bed with frustration and anxiety. Use of phones, tablets, and television in the bedroom is discouraged as these devices may make it more difficult to fall asleep.8
The next option is sleep restriction, which is useful for comorbid insomnia. Patients keep a sleep diary to better understand their sleep-wake cycle. The goal is 90% sleep efficiency, meaning that 90% of the time in bed (TIB) is spent asleep. For example, if the patient is in bed 8 hours but asleep only 4 hours, sleep efficiency is 50%. The goal is to reduce TIB to match the time asleep and to agree on a prescribed daily wake-up time. When the patient is consistently sleeping 90% of the TIB, add 30-minute increments until he or she is appropriately sleeping 7 to 8 hours at night.9 Naps are not recommended.
Let patients know that their migraine may worsen until a new routine sleep pattern emerges. This method is not recommended for patients with untreated sleep apnea.
E IS FOR EXERCISE
Exercise is broadly recommended for a healthy lifestyle; some evidence suggests that it can also be useful in the management of migraine.10 Low levels of physical activity and a sedentary lifestyle are associated with migraine.11 It is unclear if patients with migraine are less likely to exercise because they want to avoid triggering a migraine or if a sedentary lifestyle increases their risk.
Exercise has been studied for its prophylactic benefits in migraine, and one hypothesis relates to beta-endorphins. Levels of beta-endorphins are reduced in the cerebrospinal fluid of patients with migraine.12 Exercise programs may increase levels while reducing headache frequency and duration.13 One study showed that pain thresholds do not change with exercise programs, suggesting that it is avoidance behavior that is positively altered rather than the underlying pain pathways.14
A systematic review and meta-analysis based on 5 randomized controlled trials and 1 nonrandomized controlled clinical trial showed that exercise reduced monthly migraine days by only 0.6 (± 0.3) days, but the data also suggested that as the exercise intensity increased, so did the positive effects.10
Some data suggest that exercise may also reduce migraine duration and severity as well as the need for abortive medication.10 Two studies in this systematic review15,16 showed that exercise benefits were equivalent to those of migraine preventives such as amitriptyline and topiramate; the combination of amitriptyline and exercise was more beneficial than exercise alone. Multiple types of exercise were beneficial, including walking, jogging, cross-training, and cycling when done for least 6 weeks and for 30 to 50 minutes 3 to 5 times a week.
These findings are in line with the current recommendations for general health from the American College of Sports Medicine, ie, moderate to vigorous cardiorespiratory exercise for 30 to 60 minutes 3 to 5 times a week (or 150 minutes per week). The daily exercise can be continuous or done in intervals of less than 20 minutes. For those with a sedentary lifestyle, as is seen in a significant proportion of the migraine population, light to moderate exercise for less than 20 minutes is still beneficial.17
Based on this evidence, the best current recommendation for patients with migraine is to engage in graded moderate cardiorespiratory exercise, although any exercise is better than none. If a patient is sedentary or has poor exercise tolerance, or both, exercising once a week for shorter time periods may be a manageable place to start.
Some patients may identify exercise as a trigger or exacerbating factor in migraine. These patients may need appropriate prophylactic and abortive therapies before starting an exercise regimen.
THE SECOND E IS FOR EAT (FOOD AND DRINK)
Many patients believe that some foods trigger migraine attacks, but further study is needed. The most consistent food triggers appear to be red wine and caffeine (withdrawal).18,19 Interestingly, patients with migraine report low levels of alcohol consumption,20 but it is unclear if that is because alcohol has a protective effect or if patients avoid it.
Some patients may crave certain foods in the prodromal phase of an attack, eat the food, experience the attack, and falsely conclude that the food caused the attack.21 Premonitory symptoms include fatigue, cognitive changes, homeostatic changes, sensory hyperresponsiveness, and food cravings.21 It is difficult to distinguish between premonitory phase food cravings and true triggers because premonitory symptoms can precede headache by 48 to 72 hours, and the timing for a trigger to be considered causal is not known.22
Chocolate is often thought to be a migraine trigger, but the evidence argues against this and even suggests that sweet cravings are a part of the premonitory phase.23 Monosodium glutamate is often identified as a trigger as well, but the literature is inconsistent and does not support a causal relationship.24 Identifying true food triggers in migraine is difficult, and patients with migraine may have poor quality diets, with some foods acting as true triggers for certain patients.25 These possibilities have led to the development of many “migraine diets,” including elimination diets.
Elimination diets
Elimination diets involve avoiding specific food items over a period of time and then adding them back in one at a time to gauge whether they cause a reaction in the body. A number of these diets have been studied for their effects on headache and migraine:
Gluten-free diets restrict foods that contain wheat, rye, and barley. A systematic review of gluten-free diets in patients with celiac disease found that headache or migraine frequency decreased by 51.6% to 100% based on multiple cohort studies (N = 42,388).26 There are no studies on the use of a gluten-free diet for migraine in patients without celiac disease.
Immunoglobulin G-elimination diets restrict foods that serve as antigens for IgG. However, data supporting these diets are inconsistent. Two small randomized controlled trials found that the diets improved migraine symptoms, but a larger study found no improvement in the number of migraine days at 12 weeks, although there was an initially significant effect at 4 weeks.27–29
Antihistamine diets restrict foods that have high levels of histamines, including fermented dairy, vegetables, soy products, wine, beer, alcohol, and those that cause histamine release regardless of IgE testing results. A prospective single-arm study of antihistamine diets in patients with chronic headache reported symptom improvement, which could be applied to certain comorbidities such as mast cell activation syndrome.30 Another prospective nonrandomized controlled study eliminated foods based on positive IgE skin-prick testing for allergy in patients with recurrent migraine and found that it reduced headache frequency.31
Tyramine-free diets are often recommended due to the presumption that tyramine-containing foods (eg, aged cheese, cured or smoked meats and fish, and beer) are triggers. However, multiple studies have reviewed this theory with inconsistent results,32 and the only study of a tyramine-free diet was negative.33 In addition, commonly purported high-tyramine foods have lower tyramine levels than previously thought.34
Low-fat diets in migraine are supported by 2 small randomized controlled trials and a prospective study showing a decrease in symptom severity; the results for frequency are inconsistent.35–37
Low-glycemic index diets are supported in migraine by 1 randomized controlled trial that showed improvement in migraine frequency in a diet group and in a control group of patients who took a standard migraine-preventive medication to manage their symptoms.38
Other migraine diets
Diets high in certain foods or ingredient ratios, as opposed to elimination diets, have also been studied in patients with migraine. One promising diet containing high levels of omega-3 fatty acids and low levels of omega-6 fatty acids was shown in a systematic review to reduce the duration of migraine but not the frequency or severity.39 A more recent randomized controlled trial of this diet in chronic migraine also showed that it decreased migraine frequency.40
The ketogenic diet (high fat, low carbohydrate) had promising results in a randomized controlled trial in overweight women with migraine and in a prospective study.41,42 However, a prospective study of the Atkins diet in teenagers with chronic daily headaches showed no benefit.43 The ketogenic diet is difficult to follow and may work in part due to weight loss alone, although ketogenesis itself may also play a role.41,44
Sodium levels have been shown to be higher in the cerebrospinal fluid of patients with migraine than in controls, particularly during an attack.45 For a prehypertensive population or an elderly population, a low-sodium diet may be beneficial based on 2 prospective trials.46,47 However, a younger female population without hypertension and low-to-normal body mass index had a reduced probability of migraine while consuming a high-sodium diet.48
Counseling about sodium intake should be tailored to specific patient populations. For example, a diet low in sodium may be appropriate for patients with vascular risk factors such as hypertension, whereas a high-sodium diet may be appropriate in patients with comorbidities like postural tachycardia syndrome or in those with a propensity for low blood pressure or low body mass index.
Encourage routine meals and hydration
The standard advice for patients with migraine is to consume regular meals. Headaches have been associated with fasting, and those with migraine are predisposed to attacks in the setting of fasting.49,50 Migraine is more common when meals are skipped, particularly breakfast.51
It is unclear how fasting lowers the migraine threshold. Nutritional studies show that skipping meals, particularly breakfast, increases low-grade inflammation and impairs glucose metabolism by affecting insulin and fat oxidation metabolism.52 However, hypoglycemia itself is not a consistent cause of headache or migraine attacks.53 As described above, a randomized controlled trial of a low-glycemic index diet actually decreased migraine frequency and severity.38 Skipping meals also reduces energy and is associated with reduced physical activity, perhaps leading to multiple compounding triggers that further lower the migraine threshold.54,55
When counseling patients about the need to eat breakfast, consider what they normally consume (eg, is breakfast just a cup of coffee?). Replacing simple carbohydrates with protein, fats, and fiber may be beneficial for general health, but the effects on migraine are not known, nor is the optimal composition of breakfast foods.55
The optimal timing of breakfast relative to awakening is also unclear, but in general, it should be eaten within 30 to 60 minutes of rising. Also consider patients’ work hours—delayed-phase or shift workers have altered sleep cycles.
Recommendations vary in regard to hydration. Headache is associated with fluid restriction and dehydration,56,57 but only a few studies suggest that rehydration and increased hydration status can improve migraine.58 In fact, a single post hoc analysis of a metoclopramide study showed that intravenous fluid alone for patients with migraine in the emergency room did not improve pain outcomes.59
The amount of water patients should drink daily in the setting of migraine is also unknown, but a study showed benefit with 4 L, which equates to a daily intake of 16 eight-ounce glasses.60 One review on general health that could be extrapolated given the low risk of the intervention indicated that 1.8 L daily (7 to 8 eight-ounce glasses) promoted a euhydration status in most people, although many factors contribute to hydration status.61
Caffeine intake is also a major consideration. Caffeine is a nonspecific adenosine receptor antagonist that modulates adenosine receptors like the pronociceptive 2A receptor, leading to changes integral to the neuropathophysiology of migraine.62 Caffeine has analgesic properties at doses greater than 65 to 200 mg and augments the effects of analgesics such as acetaminophen and aspirin. Chronic caffeine use can lead to withdrawal symptoms when intake is stopped abruptly; this is thought to be due to upregulation of adenosine receptors, but the effect varies based on genetic predisposition.19
The risk of chronic daily headache may relate to high use of caffeine preceding the onset of chronification, and caffeine abstinence may improve response to acute migraine treatment.19,63 There is a dose-dependent risk of headache.64,65 Current recommendations suggest limiting caffeine consumption to less than 200 mg per day or stopping caffeine consumption altogether based on the quantity required for caffeine-withdrawal headache.66 Varying the caffeine dose from day to day may also trigger headache due to the high sensitivity to caffeine withdrawal.
While many diets have shown potential benefit in patients with migraine, more studies are needed before any one “migraine diet” can be recommended. Caution should be taken, as there is risk of adverse effects from nutrient deficiencies or excess levels, especially if the patient is not under the care of a healthcare professional who is familiar with the diet.
Whether it is beneficial to avoid specific food triggers at this time is unclear and still controversial even within the migraine community because some of these foods may be misattributed as triggers instead of premonitory cravings driven by the hypothalamus. It is important to counsel patients with migraine to eat a healthy diet with consistent meals, to maintain adequate hydration, and to keep their caffeine intake low or at least consistent, although these teachings are predominantly based on limited studies with extrapolation from nutrition research.
D IS FOR DIARY
A headache diary is a recommended part of headache management and may enhance the accuracy of diagnosis and assist in treatment modifications. Paper and electronic diaries have been used. Electronic diaries may be more accurate for real-time use, but patients may be more likely to complete a paper one.67 Patients prefer electronic diaries over long paper forms,68 but a practical issue to consider is easy electronic access.
Patients can start keeping a headache diary before the initial consultation to assist with diagnosis, or early in their management. A first-appointment diary mailed with instructions is a feasible option.69 These types of diaries ask detailed questions to help diagnose all major primary headache types including menstrual migraine and to identify concomitant medication-overuse headache. Physicians and patients generally report improved communication with use of a diary.70
Some providers distinguish between a headache diary and a calendar. In standard practice, a headache diary is the general term referring to both, but the literature differentiates between the two. Both should at least include headache frequency, with possible inclusion of other factors such as headache duration, headache intensity, analgesic use, headache impact on function, and absenteeism. Potential triggers including menses can also be tracked. The calendar version can fit on a single page and can be used for simple tracking of headache frequency and analgesia use.
One of the simplest calendars to use is the “stoplight” calendar. Red days are when a patient is completely debilitated in bed. On a yellow day, function at work, school, or daily activities is significantly reduced by migraine, but the patient is not bedbound. A green day is when headache is present but function is not affected. No color is placed if the patient is 100% headache-free.
Acute treatment use can be written in or, to improve compliance, a checkmark can be placed on days of treatment. Patients who are tracking menses circle the days of menstruation. The calendar-diary should be brought to every appointment to track treatment response and medication use.
THE SECOND S IS FOR STRESS
Behavioral management such as cognitive behavioral therapy in migraine has been shown to decrease catastrophizing, migraine disability, and headache severity and frequency.74 Both depression and anxiety can improve along with migraine.75 Cognitive behavioral therapy can be provided in individualized sessions or group sessions, either in person or online.74,76,77 The effects become more prominent about 5 weeks into treatment.78
Biofeedback, which uses behavioral techniques paired with physiologic autonomic measures, has been extensively studied, and shows benefit in migraine, including in meta-analysis.79 The types of biofeedback measurements used include electromyography, electroencephalography, temperature, sweat sensors, heart rate, blood volume pulse feedback, and respiration bands. While biofeedback is generally done under the guidance of a therapist, it can still be useful with minimal therapist contact and supplemental audio.80
Mindfulness, or the awareness of thoughts, feelings, and sensations in the present moment without judgment, is a behavioral technique that can be done alone or paired with another technique. It is often taught through a mindfulness-based stress-reduction program, which relies on a standardized approach. A meta-analysis showed that mindfulness improves pain intensity, headache frequency, disability, self-efficacy, and quality of life.81 It may work by encouraging pain acceptance.82
Relaxation techniques are also employed in migraine management, either alone or in conjunction with techniques mentioned above, such as mindfulness. They include progressive muscle relaxation and deep breathing. Relaxation has been shown to be effective when done by professional trainers as well as lay trainers in both individual and group settings.83,84
In patients with intractable headache, more-intensive inpatient and outpatient programs have been tried. Inpatient admissions with multidisciplinary programs that include a focus on behavioral techniques often paired with lifestyle education and sometimes pharmacologic management can be beneficial.85,86 These programs have also been successfully conducted as multiple outpatient sessions.86–88
Stress management is an important aspect of migraine management. These treatments often involve homework and require active participation.
LIFESTYLE FOR ALL
All patients with migraine should initiate lifestyle modifications (see Advice to patients with migraine: SEEDS for success). Modifications with the highest level of evidence, specifically behavioral techniques, have had the most reproducible results. A headache diary is an essential tool to identify patterns and needs for optimization of acute or preventive treatment regimens. The strongest evidence is for the behavioral management techniques for stress reduction.
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- Krause SJ, Stillman MJ, Tepper DE, Zajac D. A prospective cohort study of outpatient interdisciplinary rehabilitation of chronic headache patients. Headache 2017; 57(3):428–440. doi:10.1111/head.13020
Migraine is the second leading cause of years of life lived with a disability globally.1 It affects people of all ages, but particularly during the years associated with the highest productivity in terms of work and family life.
Migraine is a genetic neurologic disease that can be influenced or triggered by environmental factors. However, triggers do not cause migraine. For example, stress does not cause migraine, but it can exacerbate it.
Primary care physicians can help patients reduce the likelihood of a migraine attack, the severity of symptoms, or both by offering lifestyle counseling centered around the mnemonic SEEDS: sleep, exercise, eat, diary, and stress. In this article, each factor is discussed individually for its current support in the literature along with best-practice recommendations.
S IS FOR SLEEP
Before optimizing sleep hygiene, screen for sleep apnea, especially in those who have chronic daily headache upon awakening. An excellent tool is the STOP-Bang screening questionnaire5 (www.stopbang.ca/osa/screening.php). Patients respond “yes” or “no” to the following questions:
- Snoring: Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?
- Tired: Do you often feel tired, fatigued, or sleepy during the daytime?
- Observed: Has anyone observed you stop breathing during your sleep?
- Pressure: Do you have or are you being treated for high blood pressure?
- Body mass index greater than 35 kg/m2?
- Age over 50?
- Neck circumference larger than 40 cm (females) or 42 cm (males)?
- Gender—male?
Each “yes” answer is scored as 1 point. A score less than 3 indicates low risk of obstructive sleep apnea; 3 to 4 indicates moderate risk; and 5 or more indicates high risk. Optimization of sleep apnea with continuous positive airway pressure therapy can improve sleep apnea headache.6 The improved sleep from reduced arousals may also mitigate migraine symptoms.
Behavioral modification for sleep hygiene can convert chronic migraine to episodic migraine.7 One such program is stimulus control therapy, which focuses on using cues to initiate sleep (Table 1). Patients are encouraged to keep the bedroom quiet, dark, and cool, and to go to sleep at the same time every night. Importantly, the bed should be associated only with sleep. If patients are unable to fall asleep within 20 to 30 minutes, they should leave the room so they do not associate the bed with frustration and anxiety. Use of phones, tablets, and television in the bedroom is discouraged as these devices may make it more difficult to fall asleep.8
The next option is sleep restriction, which is useful for comorbid insomnia. Patients keep a sleep diary to better understand their sleep-wake cycle. The goal is 90% sleep efficiency, meaning that 90% of the time in bed (TIB) is spent asleep. For example, if the patient is in bed 8 hours but asleep only 4 hours, sleep efficiency is 50%. The goal is to reduce TIB to match the time asleep and to agree on a prescribed daily wake-up time. When the patient is consistently sleeping 90% of the TIB, add 30-minute increments until he or she is appropriately sleeping 7 to 8 hours at night.9 Naps are not recommended.
Let patients know that their migraine may worsen until a new routine sleep pattern emerges. This method is not recommended for patients with untreated sleep apnea.
E IS FOR EXERCISE
Exercise is broadly recommended for a healthy lifestyle; some evidence suggests that it can also be useful in the management of migraine.10 Low levels of physical activity and a sedentary lifestyle are associated with migraine.11 It is unclear if patients with migraine are less likely to exercise because they want to avoid triggering a migraine or if a sedentary lifestyle increases their risk.
Exercise has been studied for its prophylactic benefits in migraine, and one hypothesis relates to beta-endorphins. Levels of beta-endorphins are reduced in the cerebrospinal fluid of patients with migraine.12 Exercise programs may increase levels while reducing headache frequency and duration.13 One study showed that pain thresholds do not change with exercise programs, suggesting that it is avoidance behavior that is positively altered rather than the underlying pain pathways.14
A systematic review and meta-analysis based on 5 randomized controlled trials and 1 nonrandomized controlled clinical trial showed that exercise reduced monthly migraine days by only 0.6 (± 0.3) days, but the data also suggested that as the exercise intensity increased, so did the positive effects.10
Some data suggest that exercise may also reduce migraine duration and severity as well as the need for abortive medication.10 Two studies in this systematic review15,16 showed that exercise benefits were equivalent to those of migraine preventives such as amitriptyline and topiramate; the combination of amitriptyline and exercise was more beneficial than exercise alone. Multiple types of exercise were beneficial, including walking, jogging, cross-training, and cycling when done for least 6 weeks and for 30 to 50 minutes 3 to 5 times a week.
These findings are in line with the current recommendations for general health from the American College of Sports Medicine, ie, moderate to vigorous cardiorespiratory exercise for 30 to 60 minutes 3 to 5 times a week (or 150 minutes per week). The daily exercise can be continuous or done in intervals of less than 20 minutes. For those with a sedentary lifestyle, as is seen in a significant proportion of the migraine population, light to moderate exercise for less than 20 minutes is still beneficial.17
Based on this evidence, the best current recommendation for patients with migraine is to engage in graded moderate cardiorespiratory exercise, although any exercise is better than none. If a patient is sedentary or has poor exercise tolerance, or both, exercising once a week for shorter time periods may be a manageable place to start.
Some patients may identify exercise as a trigger or exacerbating factor in migraine. These patients may need appropriate prophylactic and abortive therapies before starting an exercise regimen.
THE SECOND E IS FOR EAT (FOOD AND DRINK)
Many patients believe that some foods trigger migraine attacks, but further study is needed. The most consistent food triggers appear to be red wine and caffeine (withdrawal).18,19 Interestingly, patients with migraine report low levels of alcohol consumption,20 but it is unclear if that is because alcohol has a protective effect or if patients avoid it.
Some patients may crave certain foods in the prodromal phase of an attack, eat the food, experience the attack, and falsely conclude that the food caused the attack.21 Premonitory symptoms include fatigue, cognitive changes, homeostatic changes, sensory hyperresponsiveness, and food cravings.21 It is difficult to distinguish between premonitory phase food cravings and true triggers because premonitory symptoms can precede headache by 48 to 72 hours, and the timing for a trigger to be considered causal is not known.22
Chocolate is often thought to be a migraine trigger, but the evidence argues against this and even suggests that sweet cravings are a part of the premonitory phase.23 Monosodium glutamate is often identified as a trigger as well, but the literature is inconsistent and does not support a causal relationship.24 Identifying true food triggers in migraine is difficult, and patients with migraine may have poor quality diets, with some foods acting as true triggers for certain patients.25 These possibilities have led to the development of many “migraine diets,” including elimination diets.
Elimination diets
Elimination diets involve avoiding specific food items over a period of time and then adding them back in one at a time to gauge whether they cause a reaction in the body. A number of these diets have been studied for their effects on headache and migraine:
Gluten-free diets restrict foods that contain wheat, rye, and barley. A systematic review of gluten-free diets in patients with celiac disease found that headache or migraine frequency decreased by 51.6% to 100% based on multiple cohort studies (N = 42,388).26 There are no studies on the use of a gluten-free diet for migraine in patients without celiac disease.
Immunoglobulin G-elimination diets restrict foods that serve as antigens for IgG. However, data supporting these diets are inconsistent. Two small randomized controlled trials found that the diets improved migraine symptoms, but a larger study found no improvement in the number of migraine days at 12 weeks, although there was an initially significant effect at 4 weeks.27–29
Antihistamine diets restrict foods that have high levels of histamines, including fermented dairy, vegetables, soy products, wine, beer, alcohol, and those that cause histamine release regardless of IgE testing results. A prospective single-arm study of antihistamine diets in patients with chronic headache reported symptom improvement, which could be applied to certain comorbidities such as mast cell activation syndrome.30 Another prospective nonrandomized controlled study eliminated foods based on positive IgE skin-prick testing for allergy in patients with recurrent migraine and found that it reduced headache frequency.31
Tyramine-free diets are often recommended due to the presumption that tyramine-containing foods (eg, aged cheese, cured or smoked meats and fish, and beer) are triggers. However, multiple studies have reviewed this theory with inconsistent results,32 and the only study of a tyramine-free diet was negative.33 In addition, commonly purported high-tyramine foods have lower tyramine levels than previously thought.34
Low-fat diets in migraine are supported by 2 small randomized controlled trials and a prospective study showing a decrease in symptom severity; the results for frequency are inconsistent.35–37
Low-glycemic index diets are supported in migraine by 1 randomized controlled trial that showed improvement in migraine frequency in a diet group and in a control group of patients who took a standard migraine-preventive medication to manage their symptoms.38
Other migraine diets
Diets high in certain foods or ingredient ratios, as opposed to elimination diets, have also been studied in patients with migraine. One promising diet containing high levels of omega-3 fatty acids and low levels of omega-6 fatty acids was shown in a systematic review to reduce the duration of migraine but not the frequency or severity.39 A more recent randomized controlled trial of this diet in chronic migraine also showed that it decreased migraine frequency.40
The ketogenic diet (high fat, low carbohydrate) had promising results in a randomized controlled trial in overweight women with migraine and in a prospective study.41,42 However, a prospective study of the Atkins diet in teenagers with chronic daily headaches showed no benefit.43 The ketogenic diet is difficult to follow and may work in part due to weight loss alone, although ketogenesis itself may also play a role.41,44
Sodium levels have been shown to be higher in the cerebrospinal fluid of patients with migraine than in controls, particularly during an attack.45 For a prehypertensive population or an elderly population, a low-sodium diet may be beneficial based on 2 prospective trials.46,47 However, a younger female population without hypertension and low-to-normal body mass index had a reduced probability of migraine while consuming a high-sodium diet.48
Counseling about sodium intake should be tailored to specific patient populations. For example, a diet low in sodium may be appropriate for patients with vascular risk factors such as hypertension, whereas a high-sodium diet may be appropriate in patients with comorbidities like postural tachycardia syndrome or in those with a propensity for low blood pressure or low body mass index.
Encourage routine meals and hydration
The standard advice for patients with migraine is to consume regular meals. Headaches have been associated with fasting, and those with migraine are predisposed to attacks in the setting of fasting.49,50 Migraine is more common when meals are skipped, particularly breakfast.51
It is unclear how fasting lowers the migraine threshold. Nutritional studies show that skipping meals, particularly breakfast, increases low-grade inflammation and impairs glucose metabolism by affecting insulin and fat oxidation metabolism.52 However, hypoglycemia itself is not a consistent cause of headache or migraine attacks.53 As described above, a randomized controlled trial of a low-glycemic index diet actually decreased migraine frequency and severity.38 Skipping meals also reduces energy and is associated with reduced physical activity, perhaps leading to multiple compounding triggers that further lower the migraine threshold.54,55
When counseling patients about the need to eat breakfast, consider what they normally consume (eg, is breakfast just a cup of coffee?). Replacing simple carbohydrates with protein, fats, and fiber may be beneficial for general health, but the effects on migraine are not known, nor is the optimal composition of breakfast foods.55
The optimal timing of breakfast relative to awakening is also unclear, but in general, it should be eaten within 30 to 60 minutes of rising. Also consider patients’ work hours—delayed-phase or shift workers have altered sleep cycles.
Recommendations vary in regard to hydration. Headache is associated with fluid restriction and dehydration,56,57 but only a few studies suggest that rehydration and increased hydration status can improve migraine.58 In fact, a single post hoc analysis of a metoclopramide study showed that intravenous fluid alone for patients with migraine in the emergency room did not improve pain outcomes.59
The amount of water patients should drink daily in the setting of migraine is also unknown, but a study showed benefit with 4 L, which equates to a daily intake of 16 eight-ounce glasses.60 One review on general health that could be extrapolated given the low risk of the intervention indicated that 1.8 L daily (7 to 8 eight-ounce glasses) promoted a euhydration status in most people, although many factors contribute to hydration status.61
Caffeine intake is also a major consideration. Caffeine is a nonspecific adenosine receptor antagonist that modulates adenosine receptors like the pronociceptive 2A receptor, leading to changes integral to the neuropathophysiology of migraine.62 Caffeine has analgesic properties at doses greater than 65 to 200 mg and augments the effects of analgesics such as acetaminophen and aspirin. Chronic caffeine use can lead to withdrawal symptoms when intake is stopped abruptly; this is thought to be due to upregulation of adenosine receptors, but the effect varies based on genetic predisposition.19
The risk of chronic daily headache may relate to high use of caffeine preceding the onset of chronification, and caffeine abstinence may improve response to acute migraine treatment.19,63 There is a dose-dependent risk of headache.64,65 Current recommendations suggest limiting caffeine consumption to less than 200 mg per day or stopping caffeine consumption altogether based on the quantity required for caffeine-withdrawal headache.66 Varying the caffeine dose from day to day may also trigger headache due to the high sensitivity to caffeine withdrawal.
While many diets have shown potential benefit in patients with migraine, more studies are needed before any one “migraine diet” can be recommended. Caution should be taken, as there is risk of adverse effects from nutrient deficiencies or excess levels, especially if the patient is not under the care of a healthcare professional who is familiar with the diet.
Whether it is beneficial to avoid specific food triggers at this time is unclear and still controversial even within the migraine community because some of these foods may be misattributed as triggers instead of premonitory cravings driven by the hypothalamus. It is important to counsel patients with migraine to eat a healthy diet with consistent meals, to maintain adequate hydration, and to keep their caffeine intake low or at least consistent, although these teachings are predominantly based on limited studies with extrapolation from nutrition research.
D IS FOR DIARY
A headache diary is a recommended part of headache management and may enhance the accuracy of diagnosis and assist in treatment modifications. Paper and electronic diaries have been used. Electronic diaries may be more accurate for real-time use, but patients may be more likely to complete a paper one.67 Patients prefer electronic diaries over long paper forms,68 but a practical issue to consider is easy electronic access.
Patients can start keeping a headache diary before the initial consultation to assist with diagnosis, or early in their management. A first-appointment diary mailed with instructions is a feasible option.69 These types of diaries ask detailed questions to help diagnose all major primary headache types including menstrual migraine and to identify concomitant medication-overuse headache. Physicians and patients generally report improved communication with use of a diary.70
Some providers distinguish between a headache diary and a calendar. In standard practice, a headache diary is the general term referring to both, but the literature differentiates between the two. Both should at least include headache frequency, with possible inclusion of other factors such as headache duration, headache intensity, analgesic use, headache impact on function, and absenteeism. Potential triggers including menses can also be tracked. The calendar version can fit on a single page and can be used for simple tracking of headache frequency and analgesia use.
One of the simplest calendars to use is the “stoplight” calendar. Red days are when a patient is completely debilitated in bed. On a yellow day, function at work, school, or daily activities is significantly reduced by migraine, but the patient is not bedbound. A green day is when headache is present but function is not affected. No color is placed if the patient is 100% headache-free.
Acute treatment use can be written in or, to improve compliance, a checkmark can be placed on days of treatment. Patients who are tracking menses circle the days of menstruation. The calendar-diary should be brought to every appointment to track treatment response and medication use.
THE SECOND S IS FOR STRESS
Behavioral management such as cognitive behavioral therapy in migraine has been shown to decrease catastrophizing, migraine disability, and headache severity and frequency.74 Both depression and anxiety can improve along with migraine.75 Cognitive behavioral therapy can be provided in individualized sessions or group sessions, either in person or online.74,76,77 The effects become more prominent about 5 weeks into treatment.78
Biofeedback, which uses behavioral techniques paired with physiologic autonomic measures, has been extensively studied, and shows benefit in migraine, including in meta-analysis.79 The types of biofeedback measurements used include electromyography, electroencephalography, temperature, sweat sensors, heart rate, blood volume pulse feedback, and respiration bands. While biofeedback is generally done under the guidance of a therapist, it can still be useful with minimal therapist contact and supplemental audio.80
Mindfulness, or the awareness of thoughts, feelings, and sensations in the present moment without judgment, is a behavioral technique that can be done alone or paired with another technique. It is often taught through a mindfulness-based stress-reduction program, which relies on a standardized approach. A meta-analysis showed that mindfulness improves pain intensity, headache frequency, disability, self-efficacy, and quality of life.81 It may work by encouraging pain acceptance.82
Relaxation techniques are also employed in migraine management, either alone or in conjunction with techniques mentioned above, such as mindfulness. They include progressive muscle relaxation and deep breathing. Relaxation has been shown to be effective when done by professional trainers as well as lay trainers in both individual and group settings.83,84
In patients with intractable headache, more-intensive inpatient and outpatient programs have been tried. Inpatient admissions with multidisciplinary programs that include a focus on behavioral techniques often paired with lifestyle education and sometimes pharmacologic management can be beneficial.85,86 These programs have also been successfully conducted as multiple outpatient sessions.86–88
Stress management is an important aspect of migraine management. These treatments often involve homework and require active participation.
LIFESTYLE FOR ALL
All patients with migraine should initiate lifestyle modifications (see Advice to patients with migraine: SEEDS for success). Modifications with the highest level of evidence, specifically behavioral techniques, have had the most reproducible results. A headache diary is an essential tool to identify patterns and needs for optimization of acute or preventive treatment regimens. The strongest evidence is for the behavioral management techniques for stress reduction.
Migraine is the second leading cause of years of life lived with a disability globally.1 It affects people of all ages, but particularly during the years associated with the highest productivity in terms of work and family life.
Migraine is a genetic neurologic disease that can be influenced or triggered by environmental factors. However, triggers do not cause migraine. For example, stress does not cause migraine, but it can exacerbate it.
Primary care physicians can help patients reduce the likelihood of a migraine attack, the severity of symptoms, or both by offering lifestyle counseling centered around the mnemonic SEEDS: sleep, exercise, eat, diary, and stress. In this article, each factor is discussed individually for its current support in the literature along with best-practice recommendations.
S IS FOR SLEEP
Before optimizing sleep hygiene, screen for sleep apnea, especially in those who have chronic daily headache upon awakening. An excellent tool is the STOP-Bang screening questionnaire5 (www.stopbang.ca/osa/screening.php). Patients respond “yes” or “no” to the following questions:
- Snoring: Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?
- Tired: Do you often feel tired, fatigued, or sleepy during the daytime?
- Observed: Has anyone observed you stop breathing during your sleep?
- Pressure: Do you have or are you being treated for high blood pressure?
- Body mass index greater than 35 kg/m2?
- Age over 50?
- Neck circumference larger than 40 cm (females) or 42 cm (males)?
- Gender—male?
Each “yes” answer is scored as 1 point. A score less than 3 indicates low risk of obstructive sleep apnea; 3 to 4 indicates moderate risk; and 5 or more indicates high risk. Optimization of sleep apnea with continuous positive airway pressure therapy can improve sleep apnea headache.6 The improved sleep from reduced arousals may also mitigate migraine symptoms.
Behavioral modification for sleep hygiene can convert chronic migraine to episodic migraine.7 One such program is stimulus control therapy, which focuses on using cues to initiate sleep (Table 1). Patients are encouraged to keep the bedroom quiet, dark, and cool, and to go to sleep at the same time every night. Importantly, the bed should be associated only with sleep. If patients are unable to fall asleep within 20 to 30 minutes, they should leave the room so they do not associate the bed with frustration and anxiety. Use of phones, tablets, and television in the bedroom is discouraged as these devices may make it more difficult to fall asleep.8
The next option is sleep restriction, which is useful for comorbid insomnia. Patients keep a sleep diary to better understand their sleep-wake cycle. The goal is 90% sleep efficiency, meaning that 90% of the time in bed (TIB) is spent asleep. For example, if the patient is in bed 8 hours but asleep only 4 hours, sleep efficiency is 50%. The goal is to reduce TIB to match the time asleep and to agree on a prescribed daily wake-up time. When the patient is consistently sleeping 90% of the TIB, add 30-minute increments until he or she is appropriately sleeping 7 to 8 hours at night.9 Naps are not recommended.
Let patients know that their migraine may worsen until a new routine sleep pattern emerges. This method is not recommended for patients with untreated sleep apnea.
E IS FOR EXERCISE
Exercise is broadly recommended for a healthy lifestyle; some evidence suggests that it can also be useful in the management of migraine.10 Low levels of physical activity and a sedentary lifestyle are associated with migraine.11 It is unclear if patients with migraine are less likely to exercise because they want to avoid triggering a migraine or if a sedentary lifestyle increases their risk.
Exercise has been studied for its prophylactic benefits in migraine, and one hypothesis relates to beta-endorphins. Levels of beta-endorphins are reduced in the cerebrospinal fluid of patients with migraine.12 Exercise programs may increase levels while reducing headache frequency and duration.13 One study showed that pain thresholds do not change with exercise programs, suggesting that it is avoidance behavior that is positively altered rather than the underlying pain pathways.14
A systematic review and meta-analysis based on 5 randomized controlled trials and 1 nonrandomized controlled clinical trial showed that exercise reduced monthly migraine days by only 0.6 (± 0.3) days, but the data also suggested that as the exercise intensity increased, so did the positive effects.10
Some data suggest that exercise may also reduce migraine duration and severity as well as the need for abortive medication.10 Two studies in this systematic review15,16 showed that exercise benefits were equivalent to those of migraine preventives such as amitriptyline and topiramate; the combination of amitriptyline and exercise was more beneficial than exercise alone. Multiple types of exercise were beneficial, including walking, jogging, cross-training, and cycling when done for least 6 weeks and for 30 to 50 minutes 3 to 5 times a week.
These findings are in line with the current recommendations for general health from the American College of Sports Medicine, ie, moderate to vigorous cardiorespiratory exercise for 30 to 60 minutes 3 to 5 times a week (or 150 minutes per week). The daily exercise can be continuous or done in intervals of less than 20 minutes. For those with a sedentary lifestyle, as is seen in a significant proportion of the migraine population, light to moderate exercise for less than 20 minutes is still beneficial.17
Based on this evidence, the best current recommendation for patients with migraine is to engage in graded moderate cardiorespiratory exercise, although any exercise is better than none. If a patient is sedentary or has poor exercise tolerance, or both, exercising once a week for shorter time periods may be a manageable place to start.
Some patients may identify exercise as a trigger or exacerbating factor in migraine. These patients may need appropriate prophylactic and abortive therapies before starting an exercise regimen.
THE SECOND E IS FOR EAT (FOOD AND DRINK)
Many patients believe that some foods trigger migraine attacks, but further study is needed. The most consistent food triggers appear to be red wine and caffeine (withdrawal).18,19 Interestingly, patients with migraine report low levels of alcohol consumption,20 but it is unclear if that is because alcohol has a protective effect or if patients avoid it.
Some patients may crave certain foods in the prodromal phase of an attack, eat the food, experience the attack, and falsely conclude that the food caused the attack.21 Premonitory symptoms include fatigue, cognitive changes, homeostatic changes, sensory hyperresponsiveness, and food cravings.21 It is difficult to distinguish between premonitory phase food cravings and true triggers because premonitory symptoms can precede headache by 48 to 72 hours, and the timing for a trigger to be considered causal is not known.22
Chocolate is often thought to be a migraine trigger, but the evidence argues against this and even suggests that sweet cravings are a part of the premonitory phase.23 Monosodium glutamate is often identified as a trigger as well, but the literature is inconsistent and does not support a causal relationship.24 Identifying true food triggers in migraine is difficult, and patients with migraine may have poor quality diets, with some foods acting as true triggers for certain patients.25 These possibilities have led to the development of many “migraine diets,” including elimination diets.
Elimination diets
Elimination diets involve avoiding specific food items over a period of time and then adding them back in one at a time to gauge whether they cause a reaction in the body. A number of these diets have been studied for their effects on headache and migraine:
Gluten-free diets restrict foods that contain wheat, rye, and barley. A systematic review of gluten-free diets in patients with celiac disease found that headache or migraine frequency decreased by 51.6% to 100% based on multiple cohort studies (N = 42,388).26 There are no studies on the use of a gluten-free diet for migraine in patients without celiac disease.
Immunoglobulin G-elimination diets restrict foods that serve as antigens for IgG. However, data supporting these diets are inconsistent. Two small randomized controlled trials found that the diets improved migraine symptoms, but a larger study found no improvement in the number of migraine days at 12 weeks, although there was an initially significant effect at 4 weeks.27–29
Antihistamine diets restrict foods that have high levels of histamines, including fermented dairy, vegetables, soy products, wine, beer, alcohol, and those that cause histamine release regardless of IgE testing results. A prospective single-arm study of antihistamine diets in patients with chronic headache reported symptom improvement, which could be applied to certain comorbidities such as mast cell activation syndrome.30 Another prospective nonrandomized controlled study eliminated foods based on positive IgE skin-prick testing for allergy in patients with recurrent migraine and found that it reduced headache frequency.31
Tyramine-free diets are often recommended due to the presumption that tyramine-containing foods (eg, aged cheese, cured or smoked meats and fish, and beer) are triggers. However, multiple studies have reviewed this theory with inconsistent results,32 and the only study of a tyramine-free diet was negative.33 In addition, commonly purported high-tyramine foods have lower tyramine levels than previously thought.34
Low-fat diets in migraine are supported by 2 small randomized controlled trials and a prospective study showing a decrease in symptom severity; the results for frequency are inconsistent.35–37
Low-glycemic index diets are supported in migraine by 1 randomized controlled trial that showed improvement in migraine frequency in a diet group and in a control group of patients who took a standard migraine-preventive medication to manage their symptoms.38
Other migraine diets
Diets high in certain foods or ingredient ratios, as opposed to elimination diets, have also been studied in patients with migraine. One promising diet containing high levels of omega-3 fatty acids and low levels of omega-6 fatty acids was shown in a systematic review to reduce the duration of migraine but not the frequency or severity.39 A more recent randomized controlled trial of this diet in chronic migraine also showed that it decreased migraine frequency.40
The ketogenic diet (high fat, low carbohydrate) had promising results in a randomized controlled trial in overweight women with migraine and in a prospective study.41,42 However, a prospective study of the Atkins diet in teenagers with chronic daily headaches showed no benefit.43 The ketogenic diet is difficult to follow and may work in part due to weight loss alone, although ketogenesis itself may also play a role.41,44
Sodium levels have been shown to be higher in the cerebrospinal fluid of patients with migraine than in controls, particularly during an attack.45 For a prehypertensive population or an elderly population, a low-sodium diet may be beneficial based on 2 prospective trials.46,47 However, a younger female population without hypertension and low-to-normal body mass index had a reduced probability of migraine while consuming a high-sodium diet.48
Counseling about sodium intake should be tailored to specific patient populations. For example, a diet low in sodium may be appropriate for patients with vascular risk factors such as hypertension, whereas a high-sodium diet may be appropriate in patients with comorbidities like postural tachycardia syndrome or in those with a propensity for low blood pressure or low body mass index.
Encourage routine meals and hydration
The standard advice for patients with migraine is to consume regular meals. Headaches have been associated with fasting, and those with migraine are predisposed to attacks in the setting of fasting.49,50 Migraine is more common when meals are skipped, particularly breakfast.51
It is unclear how fasting lowers the migraine threshold. Nutritional studies show that skipping meals, particularly breakfast, increases low-grade inflammation and impairs glucose metabolism by affecting insulin and fat oxidation metabolism.52 However, hypoglycemia itself is not a consistent cause of headache or migraine attacks.53 As described above, a randomized controlled trial of a low-glycemic index diet actually decreased migraine frequency and severity.38 Skipping meals also reduces energy and is associated with reduced physical activity, perhaps leading to multiple compounding triggers that further lower the migraine threshold.54,55
When counseling patients about the need to eat breakfast, consider what they normally consume (eg, is breakfast just a cup of coffee?). Replacing simple carbohydrates with protein, fats, and fiber may be beneficial for general health, but the effects on migraine are not known, nor is the optimal composition of breakfast foods.55
The optimal timing of breakfast relative to awakening is also unclear, but in general, it should be eaten within 30 to 60 minutes of rising. Also consider patients’ work hours—delayed-phase or shift workers have altered sleep cycles.
Recommendations vary in regard to hydration. Headache is associated with fluid restriction and dehydration,56,57 but only a few studies suggest that rehydration and increased hydration status can improve migraine.58 In fact, a single post hoc analysis of a metoclopramide study showed that intravenous fluid alone for patients with migraine in the emergency room did not improve pain outcomes.59
The amount of water patients should drink daily in the setting of migraine is also unknown, but a study showed benefit with 4 L, which equates to a daily intake of 16 eight-ounce glasses.60 One review on general health that could be extrapolated given the low risk of the intervention indicated that 1.8 L daily (7 to 8 eight-ounce glasses) promoted a euhydration status in most people, although many factors contribute to hydration status.61
Caffeine intake is also a major consideration. Caffeine is a nonspecific adenosine receptor antagonist that modulates adenosine receptors like the pronociceptive 2A receptor, leading to changes integral to the neuropathophysiology of migraine.62 Caffeine has analgesic properties at doses greater than 65 to 200 mg and augments the effects of analgesics such as acetaminophen and aspirin. Chronic caffeine use can lead to withdrawal symptoms when intake is stopped abruptly; this is thought to be due to upregulation of adenosine receptors, but the effect varies based on genetic predisposition.19
The risk of chronic daily headache may relate to high use of caffeine preceding the onset of chronification, and caffeine abstinence may improve response to acute migraine treatment.19,63 There is a dose-dependent risk of headache.64,65 Current recommendations suggest limiting caffeine consumption to less than 200 mg per day or stopping caffeine consumption altogether based on the quantity required for caffeine-withdrawal headache.66 Varying the caffeine dose from day to day may also trigger headache due to the high sensitivity to caffeine withdrawal.
While many diets have shown potential benefit in patients with migraine, more studies are needed before any one “migraine diet” can be recommended. Caution should be taken, as there is risk of adverse effects from nutrient deficiencies or excess levels, especially if the patient is not under the care of a healthcare professional who is familiar with the diet.
Whether it is beneficial to avoid specific food triggers at this time is unclear and still controversial even within the migraine community because some of these foods may be misattributed as triggers instead of premonitory cravings driven by the hypothalamus. It is important to counsel patients with migraine to eat a healthy diet with consistent meals, to maintain adequate hydration, and to keep their caffeine intake low or at least consistent, although these teachings are predominantly based on limited studies with extrapolation from nutrition research.
D IS FOR DIARY
A headache diary is a recommended part of headache management and may enhance the accuracy of diagnosis and assist in treatment modifications. Paper and electronic diaries have been used. Electronic diaries may be more accurate for real-time use, but patients may be more likely to complete a paper one.67 Patients prefer electronic diaries over long paper forms,68 but a practical issue to consider is easy electronic access.
Patients can start keeping a headache diary before the initial consultation to assist with diagnosis, or early in their management. A first-appointment diary mailed with instructions is a feasible option.69 These types of diaries ask detailed questions to help diagnose all major primary headache types including menstrual migraine and to identify concomitant medication-overuse headache. Physicians and patients generally report improved communication with use of a diary.70
Some providers distinguish between a headache diary and a calendar. In standard practice, a headache diary is the general term referring to both, but the literature differentiates between the two. Both should at least include headache frequency, with possible inclusion of other factors such as headache duration, headache intensity, analgesic use, headache impact on function, and absenteeism. Potential triggers including menses can also be tracked. The calendar version can fit on a single page and can be used for simple tracking of headache frequency and analgesia use.
One of the simplest calendars to use is the “stoplight” calendar. Red days are when a patient is completely debilitated in bed. On a yellow day, function at work, school, or daily activities is significantly reduced by migraine, but the patient is not bedbound. A green day is when headache is present but function is not affected. No color is placed if the patient is 100% headache-free.
Acute treatment use can be written in or, to improve compliance, a checkmark can be placed on days of treatment. Patients who are tracking menses circle the days of menstruation. The calendar-diary should be brought to every appointment to track treatment response and medication use.
THE SECOND S IS FOR STRESS
Behavioral management such as cognitive behavioral therapy in migraine has been shown to decrease catastrophizing, migraine disability, and headache severity and frequency.74 Both depression and anxiety can improve along with migraine.75 Cognitive behavioral therapy can be provided in individualized sessions or group sessions, either in person or online.74,76,77 The effects become more prominent about 5 weeks into treatment.78
Biofeedback, which uses behavioral techniques paired with physiologic autonomic measures, has been extensively studied, and shows benefit in migraine, including in meta-analysis.79 The types of biofeedback measurements used include electromyography, electroencephalography, temperature, sweat sensors, heart rate, blood volume pulse feedback, and respiration bands. While biofeedback is generally done under the guidance of a therapist, it can still be useful with minimal therapist contact and supplemental audio.80
Mindfulness, or the awareness of thoughts, feelings, and sensations in the present moment without judgment, is a behavioral technique that can be done alone or paired with another technique. It is often taught through a mindfulness-based stress-reduction program, which relies on a standardized approach. A meta-analysis showed that mindfulness improves pain intensity, headache frequency, disability, self-efficacy, and quality of life.81 It may work by encouraging pain acceptance.82
Relaxation techniques are also employed in migraine management, either alone or in conjunction with techniques mentioned above, such as mindfulness. They include progressive muscle relaxation and deep breathing. Relaxation has been shown to be effective when done by professional trainers as well as lay trainers in both individual and group settings.83,84
In patients with intractable headache, more-intensive inpatient and outpatient programs have been tried. Inpatient admissions with multidisciplinary programs that include a focus on behavioral techniques often paired with lifestyle education and sometimes pharmacologic management can be beneficial.85,86 These programs have also been successfully conducted as multiple outpatient sessions.86–88
Stress management is an important aspect of migraine management. These treatments often involve homework and require active participation.
LIFESTYLE FOR ALL
All patients with migraine should initiate lifestyle modifications (see Advice to patients with migraine: SEEDS for success). Modifications with the highest level of evidence, specifically behavioral techniques, have had the most reproducible results. A headache diary is an essential tool to identify patterns and needs for optimization of acute or preventive treatment regimens. The strongest evidence is for the behavioral management techniques for stress reduction.
- GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100):1211–1259. doi:10.1016/S0140-6736(17)32154-2
- Vgontzas A, Pavlovic JM. Sleep diorders and migraine: review of literature and potential pathophysiology mechanisms. Headache 2018; 58(7):1030–1039. doi:10.1111/head.13358
- Lund N, Westergaard ML, Barloese M, Glumer C, Jensen RH. Epidemiology of concurrent headache and sleep problems in Denmark. Cephalalgia 2014; 34(10):833–845. doi:10.1177/0333102414543332
- Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol 2016; 263(4):669–676. doi:10.1007/s00415-016-8031-5
- Chung F, Abdullah HR, Liao P. STOP-Bang questionnaire: a practical approach to screen for obstructive sleep apnea. Chest 2016; 149(3):631–638. doi:10.1378/chest.15-0903
- Johnson KG, Ziemba AM, Garb JL. Improvement in headaches with continuous positive airway pressure for obstructive sleep apnea: a retrospective analysis. Headache 2013; 53(2):333–343. doi:10.1111/j.1526-4610.2012.02251.x
- Calhoun AH, Ford S. Behavioral sleep modification may revert transformed migraine to episodic migraine. Headache 2007; 47(8):1178–1183. doi:10.1111/j.1526-4610.2007.00780.x
- Calhoun AH, Ford S, Finkel AG, Kahn KA, Mann JD. The prevalence and spectrum of sleep problems in women with transformed migraine. Headache 2006; 46(4):604–610. doi:10.1111/j.1526-4610.2006.00410.x
- Rains JC. Optimizing circadian cycles and behavioral insomnia treatment in migraine. Curr Pain Headache Rep 2008; 12(3):213–219. pmid:18796272
- Lemmens J, De Pauw J, Van Soom T, et al. The effect of aerobic exercise on the number of migraine days, duration and pain intensity in migraine: a systematic literature review and meta-analysis. J Headache Pain 2019; 20(1):16. doi:10.1186/s10194-019-0961-8
- Amin FM, Aristeidou S, Baraldi C, et al; European Headache Federation School of Advanced Studies (EHF-SAS). The association between migraine and physical exercise. J Headache Pain 2018; 19(1):83. doi:10.1186/s10194-018-0902-y
- Genazzani AR, Nappi G, Facchinetti F, et al. Progressive impairment of CSF beta-EP levels in migraine sufferers. Pain 1984; 18:127-133. pmid:6324056
- Hindiyeh NA, Krusz JC, Cowan RP. Does exercise make migraines worse and tension type headaches better? Curr Pain Headache Rep 2013;17:380. pmid:24234818
- Kroll LS, Sjodahl Hammarlund C, Gard G, Jensen RH, Bendtsen L. Has aerobic exercise effect on pain perception in persons with migraine and coexisting tension-type headache and neck pain? A randomized, controlled, clinical trial. Eur J Pain 2018; 10:10. pmid:29635806
- Santiago MD, Carvalho Dde S, Gabbai AA, Pinto MM, Moutran AR, Villa TR. Amitriptyline and aerobic exercise or amitriptyline alone in the treatment of chronic migraine: a randomized comparative study. Arq Neuropsiquiatr 2014; 72(11):851-855. pmid:25410451
- Varkey E, Cider A, Carlsson J, Linde M. Exercise as migraine prophylaxis: a randomized study using relaxation and topiramate as controls. Cephalalgia 2011; 31(14):1428-1438. pmid:21890526
- Garber CE, Blissmer B, Deschenes MR, et al. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc 2011; 43(7):1334-1359. pmid:21694556
- Guarnieri P, Radnitz CL, Blanchard EB. Assessment of dietary risk factors in chronic headache. Biofeedback Self Regul 1990; 15(1):15–25. pmid:2361144
- Shapiro RE. Caffeine and headaches. Curr Pain Headache Rep 2008; 12(4):311–315. pmid:18625110
- Yokoyama M, Yokoyama T, Funazu K, et al. Associations between headache and stress, alcohol drinking, exercise, sleep, and comorbid health conditions in a Japanese population. J Headache Pain 2009; 10(3):177–185. doi:10.1007/s10194-009-0113-7
- Karsan N, Bose P, Goadsby PJ. The migraine premonitory phase. Continuum (Minneap Minn) 2018; 24(4, Headache):996–1008. doi:10.1212/CON.0000000000000624
- Pavlovic JM, Buse DC, Sollars CM, Haut S, Lipton RB. Trigger factors and premonitory features of migraine attacks: summary of studies. Headache 2014; 54(10):1670–1679. doi:10.1111/head.12468
- Marcus DA, Scharff L, Turk D, Gourley LM. A double-blind provocative study of chocolate as a trigger of headache. Cephalalgia 1997; 17(8):855–862. doi:10.1046/j.1468-2982.1997.1708855.x
- Obayashi Y, Nagamura Y. Does monosodium glutamate really cause headache? A systematic review of human studies. J Headache Pain 2016; 17:54. doi:10.1186/s10194-016-0639-4
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- Zis P, Julian T, Hadjivassiliou M. Headache associated with coeliac disease: a systematic review and meta-analysis. Nutrients 2018; 10(10). doi:10.3390/nu10101445
- Alpay K, Ertas M, Orhan EK, Ustay DK, Lieners C, Baykan B. Diet restriction in migraine, based on IgG against foods: a clinical double-blind, randomised, cross-over trial. Cephalalgia 2010; 30(7):829–837. doi:10.1177/0333102410361404
- Aydinlar EI, Dikmen PY, Tiftikci A, et al. IgG-based elimination diet in migraine plus irritable bowel syndrome. Headache 2013; 53(3):514–525. doi:10.1111/j.1526-4610.2012.02296.x
- Mitchell N, Hewitt CE, Jayakody S, et al. Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches. Nutr J 2011; 10:85. doi:10.1186/1475-2891-10-85
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- GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100):1211–1259. doi:10.1016/S0140-6736(17)32154-2
- Vgontzas A, Pavlovic JM. Sleep diorders and migraine: review of literature and potential pathophysiology mechanisms. Headache 2018; 58(7):1030–1039. doi:10.1111/head.13358
- Lund N, Westergaard ML, Barloese M, Glumer C, Jensen RH. Epidemiology of concurrent headache and sleep problems in Denmark. Cephalalgia 2014; 34(10):833–845. doi:10.1177/0333102414543332
- Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol 2016; 263(4):669–676. doi:10.1007/s00415-016-8031-5
- Chung F, Abdullah HR, Liao P. STOP-Bang questionnaire: a practical approach to screen for obstructive sleep apnea. Chest 2016; 149(3):631–638. doi:10.1378/chest.15-0903
- Johnson KG, Ziemba AM, Garb JL. Improvement in headaches with continuous positive airway pressure for obstructive sleep apnea: a retrospective analysis. Headache 2013; 53(2):333–343. doi:10.1111/j.1526-4610.2012.02251.x
- Calhoun AH, Ford S. Behavioral sleep modification may revert transformed migraine to episodic migraine. Headache 2007; 47(8):1178–1183. doi:10.1111/j.1526-4610.2007.00780.x
- Calhoun AH, Ford S, Finkel AG, Kahn KA, Mann JD. The prevalence and spectrum of sleep problems in women with transformed migraine. Headache 2006; 46(4):604–610. doi:10.1111/j.1526-4610.2006.00410.x
- Rains JC. Optimizing circadian cycles and behavioral insomnia treatment in migraine. Curr Pain Headache Rep 2008; 12(3):213–219. pmid:18796272
- Lemmens J, De Pauw J, Van Soom T, et al. The effect of aerobic exercise on the number of migraine days, duration and pain intensity in migraine: a systematic literature review and meta-analysis. J Headache Pain 2019; 20(1):16. doi:10.1186/s10194-019-0961-8
- Amin FM, Aristeidou S, Baraldi C, et al; European Headache Federation School of Advanced Studies (EHF-SAS). The association between migraine and physical exercise. J Headache Pain 2018; 19(1):83. doi:10.1186/s10194-018-0902-y
- Genazzani AR, Nappi G, Facchinetti F, et al. Progressive impairment of CSF beta-EP levels in migraine sufferers. Pain 1984; 18:127-133. pmid:6324056
- Hindiyeh NA, Krusz JC, Cowan RP. Does exercise make migraines worse and tension type headaches better? Curr Pain Headache Rep 2013;17:380. pmid:24234818
- Kroll LS, Sjodahl Hammarlund C, Gard G, Jensen RH, Bendtsen L. Has aerobic exercise effect on pain perception in persons with migraine and coexisting tension-type headache and neck pain? A randomized, controlled, clinical trial. Eur J Pain 2018; 10:10. pmid:29635806
- Santiago MD, Carvalho Dde S, Gabbai AA, Pinto MM, Moutran AR, Villa TR. Amitriptyline and aerobic exercise or amitriptyline alone in the treatment of chronic migraine: a randomized comparative study. Arq Neuropsiquiatr 2014; 72(11):851-855. pmid:25410451
- Varkey E, Cider A, Carlsson J, Linde M. Exercise as migraine prophylaxis: a randomized study using relaxation and topiramate as controls. Cephalalgia 2011; 31(14):1428-1438. pmid:21890526
- Garber CE, Blissmer B, Deschenes MR, et al. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc 2011; 43(7):1334-1359. pmid:21694556
- Guarnieri P, Radnitz CL, Blanchard EB. Assessment of dietary risk factors in chronic headache. Biofeedback Self Regul 1990; 15(1):15–25. pmid:2361144
- Shapiro RE. Caffeine and headaches. Curr Pain Headache Rep 2008; 12(4):311–315. pmid:18625110
- Yokoyama M, Yokoyama T, Funazu K, et al. Associations between headache and stress, alcohol drinking, exercise, sleep, and comorbid health conditions in a Japanese population. J Headache Pain 2009; 10(3):177–185. doi:10.1007/s10194-009-0113-7
- Karsan N, Bose P, Goadsby PJ. The migraine premonitory phase. Continuum (Minneap Minn) 2018; 24(4, Headache):996–1008. doi:10.1212/CON.0000000000000624
- Pavlovic JM, Buse DC, Sollars CM, Haut S, Lipton RB. Trigger factors and premonitory features of migraine attacks: summary of studies. Headache 2014; 54(10):1670–1679. doi:10.1111/head.12468
- Marcus DA, Scharff L, Turk D, Gourley LM. A double-blind provocative study of chocolate as a trigger of headache. Cephalalgia 1997; 17(8):855–862. doi:10.1046/j.1468-2982.1997.1708855.x
- Obayashi Y, Nagamura Y. Does monosodium glutamate really cause headache? A systematic review of human studies. J Headache Pain 2016; 17:54. doi:10.1186/s10194-016-0639-4
- Evans EW, Lipton RB, Peterlin BL, et al. Dietary intake patterns and diet quality in a nationally representative sample of women with and without severe headache or migraine. Headache 2015; 55(4):550–561. doi:10.1111/head.12527
- Zis P, Julian T, Hadjivassiliou M. Headache associated with coeliac disease: a systematic review and meta-analysis. Nutrients 2018; 10(10). doi:10.3390/nu10101445
- Alpay K, Ertas M, Orhan EK, Ustay DK, Lieners C, Baykan B. Diet restriction in migraine, based on IgG against foods: a clinical double-blind, randomised, cross-over trial. Cephalalgia 2010; 30(7):829–837. doi:10.1177/0333102410361404
- Aydinlar EI, Dikmen PY, Tiftikci A, et al. IgG-based elimination diet in migraine plus irritable bowel syndrome. Headache 2013; 53(3):514–525. doi:10.1111/j.1526-4610.2012.02296.x
- Mitchell N, Hewitt CE, Jayakody S, et al. Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches. Nutr J 2011; 10:85. doi:10.1186/1475-2891-10-85
- Wantke F, Gotz M, Jarisch R. Histamine-free diet: treatment of choice for histamine-induced food intolerance and supporting treatment for chronic headaches. Clin Exp Allergy 1993; 23(12):982–985. pmid:10779289
- Mansfield LE, Vaughan TR, Waller SF, Haverly RW, Ting S. Food allergy and adult migraine: double-blind and mediator confirmation of an allergic etiology. Ann Allergy 1985; 55(2):126–129. pmid:4025956
- Kohlenberg RJ. Tyramine sensitivity in dietary migraine: a critical review. Headache 1982; 22(1):30–34. pmid:17152742
- Medina JL, Diamond S. The role of diet in migraine. Headache 1978; 18(1):31–34. pmid:649377
- Mosnaim AD, Freitag F, Ignacio R, et al. Apparent lack of correlation between tyramine and phenylethylamine content and the occurrence of food-precipitated migraine. Reexamination of a variety of food products frequently consumed in the United States and commonly restricted in tyramine-free diets. Headache Quarterly. Current Treatment and Research 1996; 7(3):239–249.
- Ferrara LA, Pacioni D, Di Fronzo V, et al. Low-lipid diet reduces frequency and severity of acute migraine attacks. Nutr Metab Cardiovasc Dis 2015; 25(4):370–375. doi:10.1016/j.numecd.2014.12.006
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- Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain 2014; 15:69. doi:10.1186/1129-2377-15-69
- Evcili G, Utku U, Ogun MN, Ozdemir G. Early and long period follow-up results of low glycemic index diet for migraine prophylaxis. Agri 2018; 30(1):8–11. doi:10.5505/agri.2017.62443
- Maghsoumi-Norouzabad L, Mansoori A, Abed R, Shishehbor F. Effects of omega-3 fatty acids on the frequency, severity, and duration of migraine attacks: a systematic review and meta-analysis of randomized controlled trials. Nutr Neurosci 2018; 21(9):614–623. doi:10.1080/1028415X.2017.1344371
- Soares AA, Loucana PMC, Nasi EP, Sousa KMH, Sa OMS, Silva-Neto RP. A double- blind, randomized, and placebo-controlled clinical trial with omega-3 polyunsaturated fatty acids (OPFA Ω-3) for the prevention of migraine in chronic migraine patients using amitriptyline. Nutr Neurosci 2018; 21(3):219–223. doi:10.1080/1028415X.2016.1266133
- Di Lorenzo C, Coppola G, Sirianni G, et al. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol 2015; 22(1):170–177. doi:10.1111/ene.12550
- Di Lorenzo C, Coppola G, Bracaglia M, et al. Cortical functional correlates of responsiveness to short-lasting preventive intervention with ketogenic diet in migraine: a multimodal evoked potentials study. J Headache Pain 2016; 17:58. doi:10.1186/s10194-016-0650-9
- Kossoff EH, Huffman J, Turner Z, Gladstein J. Use of the modified Atkins diet for adolescents with chronic daily headache. Cephalalgia 2010; 30(8):1014–1016. https://journals.sagepub.com/doi/full/10.1111/j.1468-2982.2009.02016.x
- Slavin M, Ailani J. A clinical approach to addressing diet with migraine patients. Curr Neurol Neurosci Rep 2017; 17(2):17. doi:10.1007/s11910-017-0721-6
- Amer M, Woodward M, Appel LJ. Effects of dietary sodium and the DASH diet on the occurrence of headaches: results from randomised multicentre DASH-sodium clinical trial. BMJ Open 2014; 4(12):e006671. doi:10.1136/bmjopen-2014-006671
- Chen L, Zhang Z, Chen W, Whelton PK, Appel LJ. Lower sodium intake and risk of headaches: results from the trial of nonpharmacologic interventions in the elderly. Am J Public Health 2016; 106(7):1270–1275. doi:10.2105/AJPH.2016.303143
- Pogoda JM, Gross NB, Arakaki X, Fonteh AN, Cowan RP, Harrington MG. Severe headache or migraine history is inversely correlated with dietary sodium intake: NHANES 1999–2004. Headache 2016; 56(4):688–698. doi:10.1111/head.12792
- Awada A, al Jumah M. The first-of-Ramadan headache. Headache 1999; 39(7):490–493. pmid:11279933
- Abu-Salameh I, Plakht Y, Ifergane G. Migraine exacerbation during Ramadan fasting. J Headache Pain 2010; 11(6):513–517. doi:10.1007/s10194-010-0242-z
- Nazari F, Safavi M, Mahmudi M. Migraine and its relation with lifestyle in women. Pain Pract 2010; 10(3):228–234. doi:10.1111/j.1533-2500.2009.00343.x
- Nas A, Mirza N, Hagele F, et al. Impact of breakfast skipping compared with dinner skipping on regulation of energy balance and metabolic risk. Am J Clin Nutr 2017; 105(6):1351–1361. doi:10.3945/ajcn.116.151332
- Torelli P, Manzoni GC. Fasting headache. Curr Pain Headache Rep 2010; 14(4):284–291. doi:10.1007/s11916-010-0119-5
- Yoshimura E, Hatamoto Y, Yonekura S, Tanaka H. Skipping breakfast reduces energy intake and physical activity in healthy women who are habitual breakfast eaters: a randomized crossover trial. Physiol Behav 2017; 174:89–94. doi:10.1016/j.physbeh.2017.03.008
- Pendergast FJ, Livingstone KM, Worsley A, McNaughton SA. Correlates of meal skipping in young adults: a systematic review. Int J Behav Nutr Phys Act 2016; 13(1):125. doi:10.1186/s12966-016-0451-1
- Maki KC, Phillips-Eakley AK, Smith KN. The effects of breakfast consumption and composition on metabolic wellness with a focus on carbohydrate metabolism. Adv Nutr 2016; 7(3):613S–621S. doi:10.3945/an.115.010314
- Shirreffs SM, Merson SJ, Fraser SM, Archer DT. The effects of fluid restriction on hydration status and subjective feelings in man. Br J Nutr 2004; 91(6):951–958. doi:10.1079/BJN20041149
- Blau JN. Water deprivation: a new migraine precipitant. Headache 2005; 45(6):757–759. doi:10.1111/j.1526-4610.2005.05143_3.x
- Price A, Burls A. Increased water intake to reduce headache: learning from a critical appraisal. J Eval Clin Pract 2015; 21(6):1212–1218. doi:10.1111/jep.12413
- Balbin JE, Nerenberg R, Baratloo A, Friedman BW. Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Am J Emerg Med 2016; 34(4):713–716. doi:10.1016/j.ajem.2015.12.080
- Spigt M, Weerkamp N, Troost J, van Schayck CP, Knottnerus JA. A randomized trial on the effects of regular water intake in patients with recurrent headaches. Fam Pract 2012; 29(4):370–375. doi:10.1093/fampra/cmr112
- Armstrong LE, Johnson EC. Water intake, water balance, and the elusive daily water requirement. Nutrients 2018; 10(12). doi:10.3390/nu10121928
- Fried NT, Elliott MB, Oshinsky ML. The role of adenosine signaling in headache: a review. Brain Sci 2017; 7(3). doi:10.3390/brainsci7030030
- Lee MJ, Choi HA, Choi H, Chung CS. Caffeine discontinuation improves acute migraine treatment: a prospective clinic-based study. J Headache Pain 2016; 17(1):71. doi:10.1186/s10194-016-0662-5
- Shirlow MJ, Mathers CD. A study of caffeine consumption and symptoms; indigestion, palpitations, tremor, headache and insomnia. Int J Epidemiol 1985; 14(2):239–248. doi:10.1093/ije/14.2.239
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- Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018; 38(1):1–211. doi:10.1177/0333102417738202
- Krogh AB, Larsson B, Salvesen O, Linde M. A comparison between prospective Internet-based and paper diary recordings of headache among adolescents in the general population. Cephalalgia 2016; 36(4):335–345. doi:10.1177/0333102415591506
- Bandarian-Balooch S, Martin PR, McNally B, Brunelli A, Mackenzie S. Electronic-diary for recording headaches, triggers, and medication use: development and evaluation. Headache 2017; 57(10):1551–1569. doi:10.1111/head.13184
- Tassorelli C, Sances G, Allena M, et al. The usefulness and applicability of a basic headache diary before first consultation: results of a pilot study conducted in two centres. Cephalalgia 2008; 28(10):1023–1030. doi:10.1111/j.1468-2982.2008.01639.x
- Baos V, Ester F, Castellanos A, et al. Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes. Int J Clin Pract 2005; 59(3):281–286. doi:10.1111/j.1742-1241.2005.00469.x
- Martin PR, MacLeod C. Behavioral management of headache triggers: avoidance of triggers is an inadequate strategy. Clin Psychol Rev 2009; 29(6):483–495. doi:10.1016/j.cpr.2009.05.002
- Giannini G, Zanigni S, Grimaldi D, et al. Cephalalgiaphobia as a feature of high-frequency migraine: a pilot study. J Headache Pain 2013; 14:49. doi:10.1186/1129-2377-14-49
- Westergaard ML, Glumer C, Hansen EH, Jensen RH. Medication overuse, healthy lifestyle behaviour and stress in chronic headache: results from a population-based representative survey. Cephalalgia 2016; 36(1):15–28. doi:10.1177/0333102415578430
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- Martin PR, Aiello R, Gilson K, Meadows G, Milgrom J, Reece J. Cognitive behavior therapy for comorbid migraine and/or tension-type headache and major depressive disorder: an exploratory randomized controlled trial. Behav Res Ther 2015; 73:8–18. doi:10.1016/j.brat.2015.07.005
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- Sorbi MJ, Balk Y, Kleiboer AM, Couturier EG. Follow-up over 20 months confirms gains of online behavioural training in frequent episodic migraine. Cephalalgia 2017; 37(3):236–250. doi:10.1177/0333102416657145
- Thorn BE, Pence LB, Ward LC, et al. A randomized clinical trial of targeted cognitive behavioral treatment to reduce catastrophizing in chronic headache sufferers. J Pain 2007; 8(12):938–949. doi:10.1016/j.jpain.2007.06.010
- Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain 2007; 128(1–2):111–127. doi:10.1016/j.pain.2006.09.007
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- Gu Q, Hou JC, Fang XM. Mindfulness meditation for primary headache pain: a meta-analysis. Chin Med J (Engl) 2018; 131(7):829–838. doi:10.4103/0366-6999.228242
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- Gaul C, van Doorn C, Webering N, et al. Clinical outcome of a headache-specific multidisciplinary treatment program and adherence to treatment recommendations in a tertiary headache center: an observational study. J Headache Pain 2011; 12(4):475–483. doi:10.1007/s10194-011-0348-y
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KEY POINTS
- Sleep: Standard sleep hygiene recommendations to maximize sleep quantity and quality.
- Exercise: 30 to 60 minutes 3 to 5 times a week.
- Eat: Regular healthy meals, adequate hydration, and low or stable caffeine intake.
- Diary: Establish a baseline pattern, assess response to treatment, and monitor analgesia to improve accuracy of migraine diagnosis.
- Stress: Cognitive behavioral therapy, mindfulness, relaxation, biofeedback, and provider-patient trust to minimize anxiety.
FDA advisory committee supports birth control patch approval
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
FROM THE FDA
Understanding your LGBTQ patients’ needs
NEW ORLEANS – One of the most important things pediatricians can do to support their lesbian, gay, bisexual, transgender (LGBT) and other gender-nonconforming patients is to ask all their patients about their feelings, preferences and experiences when it comes to gender and sexuality, according to Julie Finger, MD, MPH.
It’s equally important not to make assumptions, she told attendees at the annual meeting of the American Academy of Pediatrics. Biology and sexual and gender identity and expression can be very diverse, she said. Specifically, doctors should not assume patients are heterosexual, that bisexuality is a phase, that orientation or attraction translates directly to behavior or vice versa, or that LGBTQ patients have unsupportive families or are engaging in risky behavior. Research suggests LGB youth have slightly higher rates of early sexual debut, sexual activity or multiple partners than straight or uncertain youth, but only marginally so.
Pediatricians also cannot assume a patient’s sexual orientation based on their partner’s gender or determine a patient’s sexual orientation or gender identity based on appearance – or even that either is the same as it was on the previous visit.
What doctors can be sure of is that they do have LGBTQ patients, said Dr. Finger, and assistant professor of clinical pediatrics at Tulane University in New Orleans. According to a 2016 Morbidity and Mortality Weekly Report (2016 Aug 12; 65[9]), about 1 in 10 students in grades 9-12 are a sexual minority. About 2% of respondents identify as gay or lesbian, 6% identify as bisexual and 3% say they aren’t sure.
Knowing the terminology
Dr. Finger defined key terminology regarding gender and sexuality. She first clarified that LGBT is not the full spectrum for sexual orientation. Pansexual (fluid attraction to any sex or gender) and asexual (lack of feeling sexual attraction) can also describe sexuality, and the Q on the end of LGBTQ is often an umbrella term for “queer” or “questioning” that encompasses anyone who fits outside conventional social norms of sexual identity and gender expression.
Sexual behaviors – which include “young men who have sex with men” and “young women who have sex with women” – do not necessarily correspond as one might expect with sexual orientation or identity, which is one’s concept of their romantic or sexual feelings, attractions and desires, again reinforcing the importance of asking patients their identity and preferences.
In terms of gender, a person’s natal or biologic gender is the one assigned people at birth based on their body parts and hormones. Gender identity is a person’s understanding of their own gender, and gender expression refers to how someone acts or presents themselves and communicates their gender within their culture.
Those who identify as “gender nonconforming, genderqueer, gender fluid, or nonbinary” see their gender on a spectrum, not within the binary “male” or “female.” A cisgender person’s gender identity matches both their biological sex assigned at birth and conventional cultural norms, while a transgender person’s gender differs from the sex they were assigned at birth. Transgender women (male to female, MTF) and men (female to men, FTM) go through the process of transition, a time that can occur in weeks or years when they shift from living as one gender to another.
While it’s unclear what leads to a person’s sexual orientation – likely a combination of genetic, hormonal and environmental factors—there is no question that sexual orientation is not a “choice,” Dr Finger said. Research has also clarified that one’s sexual orientation does not result from parenting behaviors or a history of sexual abuse.
“But I would urge all of you, instead of focusing on why someone is LGBTQ, to focus on what that means for them in their life,” Dr Finger said. “How is this bearing out in terms of their relationships and their behaviors, and how do they feel about it? How are they being supported by their family or their community, and how is it impacting their lives?”
She cited findings from a Human Rights Campaign survey in 2012 of 10,000 youth aged 13-17, which found that most LGBTQ respondents became aware of their same-sex attraction at 9 years of age, though the average age of disclosures is 16, an improvement from age 21 in the 1980s.
How and what to ask
Although children start becoming conscious of gender at ages 1-2, their sense of gender usually stabilizes by age 4.
“Who should we be screening for gender nonconformity? Quite frankly, all children, because all of them have some gender identity, so we should be asking them about that,” Dr Finger said.
When children are younger, doctors can ask parents about their child’s social interactions, forms of play, dress preferences, and mood. Questions for patients themselves, adapted for their age, might include, “Do you feel more like a girl, boy, neither or both?”, “How would you like to play, cut your hair and dress?” And “What name or pronoun (he or she) fits you?”
While such conversations do not necessarily need to happen annually, doctors should especially ask youth who dress or behave in non–gender-conforming ways or who appear to have mood, behavior or social difficulties.
To understand a patient’s sexuality, ask whether they are attracted to people of their own gender or sex, a different gender or sex, both or all genders or no one, or if they’re not sure yet. Doctors can then ask how comfortable they are with their attraction and whether they have told family members or friends about them.
Sexual behavior questions should be developmentally appropriate and lead to counsel but not judgment, Dr Finger said. Her method, with adjustments for age and development, starts, “There are many way of being sexual or intimate with someone: kissing, hugging and touching, and oral sex, anal sex and vaginal sex. Have you ever had any of these experiences? Which ones? With males or females or both, or other genders?”
Then she gets more specific while remaining sensitive. Doctors can ask younger children if they have held hands or cuddled with someone, if they have kissed someone, or if they have touched another person’s private parts. They can ask teens about oral sex, vaginal sex and anal sex and then gather more details about what parts went where, which helps determine what screenings or treatment options a patient may need or desire.
Doctors can use their judgment about whether to ask questions with parents in the room or not, but as kids grow older, it’s good practice to speak to patients without their caregivers present. Doctors should also explain the rules of confidentiality to their patients and be aware of the risks of “coming out,” including family discord or rejection, problems at school or work, social stigma, bullying and harassment, physical violence and risk-taking behaviors, such as substance use, self-injury and risky sexual behaviors. A HEADSSS screen can help doctors learn if any of these are present.
Making your practice inclusive and welcoming
Fewer than one in five teens who are “out” as LGBTQ have come out to their doctor, Dr Finger cited. Most are out to their friends and classmates, and more than half are out to their family, but teens are less likely to tell their doctors.
Research suggests one reason for this is the fact that pediatricians often don’t ask. One study found that only 20% of pediatricians discussed sexual orientation with their patients (Pediatrics 2010 Apr;125:e741-7). Similarly, only 30% of family physicians brought up sexual orientation, found another study (Fam. Med. 2001 May;33[5]:376-81). The studies found physicians more often discussed condoms, HIV, sexually transmitted infections, abstinence, violence, contraception or, in the case of family physicians, sexual behaviors, and relationships.
But another reason for not being out to doctors is a history of poor experiences. A Lambda Legal Survey in 2009 of 4,916 LGBT respondents found that 8% of LGB and 27% of transgender and gender nonconforming patients had been denied care because of their identity of orientation. Eleven percent said “providers refused to touch them or used excessive precautions,” Dr Finger reported. LGBTQ patients may fear the doctor’s reaction or not keeping their identity confidential. Patients may also have internalized shame or guilt due to societal norms or homophobia, and all these barriers can reduce LGBTQ people’s willingness to seek and access to competent care.
The first step to making LGBTQ patients comfortable in your practice is to confront your own personal biases, Dr Finger said. Understand what they are and that a provider’s discomfort, even unconscious, can be damaging to the patient-provider relationship.
“If you find that this is just not something that you’re going to be comfortable doing, at the very least, I would suggest that you find providers in your area who are comfortable working with this patient population and you refer your patients to them so that they can have a good, trusting patient-provider relationship with somebody who can provide the care that they need,” Dr Finger said.
The next step is creating a safe place with zero tolerance for insensitivity by training staff to be welcoming and inclusive, assuring patients confidentiality, providing support and resources and displaying LGBTQ-affirming materials. These youth need active, visible evidence that the office will be a safe place for them.
Ways pediatricians can communicate an inclusive environment include having gender-neutral restrooms, using “parent” instead of “mother/father” and using forms and EMR prompts with gender-neutral language or multiple options for gender selection.
Screening and LGBTQ patients’ health needs
LGB youth and those who aren’t sure of their sexual orientation tend to have higher rates of substance use, including tobacco, alcohol and illicit drugs, and are more often victims of rape and other sexual violence. Their rates of depressive symptoms, bullying victimization, and suicidality are also significantly higher than in their heterosexual cisgender peers. Homelessness rates are also considerably higher in LGBTQ youth than in heterosexual cisgender youth.
One thing pediatricians can do is work with parents to ensure a patient’s school is meeting their needs. The greater risks LGBTQ youth typically face are mediated by social support, resiliency, supportive friends and family and a supportive school environment, including inclusive curricula and supportive staff.
Lesbian and bisexual women are considerably more at risk for poor sexual or reproductive outcomes, Dr Finger said. Their rates of unplanned pregnancy are double that of straight women, contributing to their higher rates of emergency contraception and abortion. They are also more likely to have more partners (male and females), to have a younger sexual debut and to be forced into sex by a male partner—yet they are far less likely to perceive themselves as at risk for a sexually transmitted infection than their peers.
This patient population therefore may need contraception counseling, including discussing their current methods and reviewing their options, including emergency contraception and possibly an advance prescription. Dr Finger also suggests having male and female condoms available in the office.
Doctors should screen all their female patients, regardless of sexuality, for chlamydia and gonorrhea, and offer routine cervical cancer screening and the HPV vaccine, as recommended by the CDC. They might consider screening for trichomoniasis, bacterial vaginosis, herpes simplex, human papillomavirus and HIV.
For men who have sex with men, the CDC recommends HIV and syphilis serology, urine/pharyngeal/rectal gonorrhea nucleic acid amplification test (NAAT), urine/rectal chlamydia NAAT, and hepatitis C screening for those who are HIV-positive—all at least once a year.
For transgender patients, doctors need to assess their STI- and HIV-related risks based on their current anatomy and sexual behaviors.
Doctors should also consider discussing pre-exposure prophylaxis (PrEP) for any youth at high risk for HIV infection if they are at least 77 pounds (35 kg). Emtricitabine/tenofovir (Truvada, Descovy) reduces the chance of sexually acquired infection by 99%, and infection acquired via drug injection by 74% when taken as prescribed.
Resources
Dr Finger noted a range of resources for LGBTQ youth and their families and providers, including the Family Acceptance Project, Gay and Lesbian Medical Association, Gay, Lesbian and Straight Education Network, GLBTQ Legal Advocates and Defenders (GLAD), Human Rights Campaign, It Gets Better Project, LGBTQ Student Resources and Support, National Center for Lesbian Rights, Parents and Friends of Lesbians and Gays (PFLAG), Safe Schools Coalition and The Trevor Project (concerning suicide risk).
NEW ORLEANS – One of the most important things pediatricians can do to support their lesbian, gay, bisexual, transgender (LGBT) and other gender-nonconforming patients is to ask all their patients about their feelings, preferences and experiences when it comes to gender and sexuality, according to Julie Finger, MD, MPH.
It’s equally important not to make assumptions, she told attendees at the annual meeting of the American Academy of Pediatrics. Biology and sexual and gender identity and expression can be very diverse, she said. Specifically, doctors should not assume patients are heterosexual, that bisexuality is a phase, that orientation or attraction translates directly to behavior or vice versa, or that LGBTQ patients have unsupportive families or are engaging in risky behavior. Research suggests LGB youth have slightly higher rates of early sexual debut, sexual activity or multiple partners than straight or uncertain youth, but only marginally so.
Pediatricians also cannot assume a patient’s sexual orientation based on their partner’s gender or determine a patient’s sexual orientation or gender identity based on appearance – or even that either is the same as it was on the previous visit.
What doctors can be sure of is that they do have LGBTQ patients, said Dr. Finger, and assistant professor of clinical pediatrics at Tulane University in New Orleans. According to a 2016 Morbidity and Mortality Weekly Report (2016 Aug 12; 65[9]), about 1 in 10 students in grades 9-12 are a sexual minority. About 2% of respondents identify as gay or lesbian, 6% identify as bisexual and 3% say they aren’t sure.
Knowing the terminology
Dr. Finger defined key terminology regarding gender and sexuality. She first clarified that LGBT is not the full spectrum for sexual orientation. Pansexual (fluid attraction to any sex or gender) and asexual (lack of feeling sexual attraction) can also describe sexuality, and the Q on the end of LGBTQ is often an umbrella term for “queer” or “questioning” that encompasses anyone who fits outside conventional social norms of sexual identity and gender expression.
Sexual behaviors – which include “young men who have sex with men” and “young women who have sex with women” – do not necessarily correspond as one might expect with sexual orientation or identity, which is one’s concept of their romantic or sexual feelings, attractions and desires, again reinforcing the importance of asking patients their identity and preferences.
In terms of gender, a person’s natal or biologic gender is the one assigned people at birth based on their body parts and hormones. Gender identity is a person’s understanding of their own gender, and gender expression refers to how someone acts or presents themselves and communicates their gender within their culture.
Those who identify as “gender nonconforming, genderqueer, gender fluid, or nonbinary” see their gender on a spectrum, not within the binary “male” or “female.” A cisgender person’s gender identity matches both their biological sex assigned at birth and conventional cultural norms, while a transgender person’s gender differs from the sex they were assigned at birth. Transgender women (male to female, MTF) and men (female to men, FTM) go through the process of transition, a time that can occur in weeks or years when they shift from living as one gender to another.
While it’s unclear what leads to a person’s sexual orientation – likely a combination of genetic, hormonal and environmental factors—there is no question that sexual orientation is not a “choice,” Dr Finger said. Research has also clarified that one’s sexual orientation does not result from parenting behaviors or a history of sexual abuse.
“But I would urge all of you, instead of focusing on why someone is LGBTQ, to focus on what that means for them in their life,” Dr Finger said. “How is this bearing out in terms of their relationships and their behaviors, and how do they feel about it? How are they being supported by their family or their community, and how is it impacting their lives?”
She cited findings from a Human Rights Campaign survey in 2012 of 10,000 youth aged 13-17, which found that most LGBTQ respondents became aware of their same-sex attraction at 9 years of age, though the average age of disclosures is 16, an improvement from age 21 in the 1980s.
How and what to ask
Although children start becoming conscious of gender at ages 1-2, their sense of gender usually stabilizes by age 4.
“Who should we be screening for gender nonconformity? Quite frankly, all children, because all of them have some gender identity, so we should be asking them about that,” Dr Finger said.
When children are younger, doctors can ask parents about their child’s social interactions, forms of play, dress preferences, and mood. Questions for patients themselves, adapted for their age, might include, “Do you feel more like a girl, boy, neither or both?”, “How would you like to play, cut your hair and dress?” And “What name or pronoun (he or she) fits you?”
While such conversations do not necessarily need to happen annually, doctors should especially ask youth who dress or behave in non–gender-conforming ways or who appear to have mood, behavior or social difficulties.
To understand a patient’s sexuality, ask whether they are attracted to people of their own gender or sex, a different gender or sex, both or all genders or no one, or if they’re not sure yet. Doctors can then ask how comfortable they are with their attraction and whether they have told family members or friends about them.
Sexual behavior questions should be developmentally appropriate and lead to counsel but not judgment, Dr Finger said. Her method, with adjustments for age and development, starts, “There are many way of being sexual or intimate with someone: kissing, hugging and touching, and oral sex, anal sex and vaginal sex. Have you ever had any of these experiences? Which ones? With males or females or both, or other genders?”
Then she gets more specific while remaining sensitive. Doctors can ask younger children if they have held hands or cuddled with someone, if they have kissed someone, or if they have touched another person’s private parts. They can ask teens about oral sex, vaginal sex and anal sex and then gather more details about what parts went where, which helps determine what screenings or treatment options a patient may need or desire.
Doctors can use their judgment about whether to ask questions with parents in the room or not, but as kids grow older, it’s good practice to speak to patients without their caregivers present. Doctors should also explain the rules of confidentiality to their patients and be aware of the risks of “coming out,” including family discord or rejection, problems at school or work, social stigma, bullying and harassment, physical violence and risk-taking behaviors, such as substance use, self-injury and risky sexual behaviors. A HEADSSS screen can help doctors learn if any of these are present.
Making your practice inclusive and welcoming
Fewer than one in five teens who are “out” as LGBTQ have come out to their doctor, Dr Finger cited. Most are out to their friends and classmates, and more than half are out to their family, but teens are less likely to tell their doctors.
Research suggests one reason for this is the fact that pediatricians often don’t ask. One study found that only 20% of pediatricians discussed sexual orientation with their patients (Pediatrics 2010 Apr;125:e741-7). Similarly, only 30% of family physicians brought up sexual orientation, found another study (Fam. Med. 2001 May;33[5]:376-81). The studies found physicians more often discussed condoms, HIV, sexually transmitted infections, abstinence, violence, contraception or, in the case of family physicians, sexual behaviors, and relationships.
But another reason for not being out to doctors is a history of poor experiences. A Lambda Legal Survey in 2009 of 4,916 LGBT respondents found that 8% of LGB and 27% of transgender and gender nonconforming patients had been denied care because of their identity of orientation. Eleven percent said “providers refused to touch them or used excessive precautions,” Dr Finger reported. LGBTQ patients may fear the doctor’s reaction or not keeping their identity confidential. Patients may also have internalized shame or guilt due to societal norms or homophobia, and all these barriers can reduce LGBTQ people’s willingness to seek and access to competent care.
The first step to making LGBTQ patients comfortable in your practice is to confront your own personal biases, Dr Finger said. Understand what they are and that a provider’s discomfort, even unconscious, can be damaging to the patient-provider relationship.
“If you find that this is just not something that you’re going to be comfortable doing, at the very least, I would suggest that you find providers in your area who are comfortable working with this patient population and you refer your patients to them so that they can have a good, trusting patient-provider relationship with somebody who can provide the care that they need,” Dr Finger said.
The next step is creating a safe place with zero tolerance for insensitivity by training staff to be welcoming and inclusive, assuring patients confidentiality, providing support and resources and displaying LGBTQ-affirming materials. These youth need active, visible evidence that the office will be a safe place for them.
Ways pediatricians can communicate an inclusive environment include having gender-neutral restrooms, using “parent” instead of “mother/father” and using forms and EMR prompts with gender-neutral language or multiple options for gender selection.
Screening and LGBTQ patients’ health needs
LGB youth and those who aren’t sure of their sexual orientation tend to have higher rates of substance use, including tobacco, alcohol and illicit drugs, and are more often victims of rape and other sexual violence. Their rates of depressive symptoms, bullying victimization, and suicidality are also significantly higher than in their heterosexual cisgender peers. Homelessness rates are also considerably higher in LGBTQ youth than in heterosexual cisgender youth.
One thing pediatricians can do is work with parents to ensure a patient’s school is meeting their needs. The greater risks LGBTQ youth typically face are mediated by social support, resiliency, supportive friends and family and a supportive school environment, including inclusive curricula and supportive staff.
Lesbian and bisexual women are considerably more at risk for poor sexual or reproductive outcomes, Dr Finger said. Their rates of unplanned pregnancy are double that of straight women, contributing to their higher rates of emergency contraception and abortion. They are also more likely to have more partners (male and females), to have a younger sexual debut and to be forced into sex by a male partner—yet they are far less likely to perceive themselves as at risk for a sexually transmitted infection than their peers.
This patient population therefore may need contraception counseling, including discussing their current methods and reviewing their options, including emergency contraception and possibly an advance prescription. Dr Finger also suggests having male and female condoms available in the office.
Doctors should screen all their female patients, regardless of sexuality, for chlamydia and gonorrhea, and offer routine cervical cancer screening and the HPV vaccine, as recommended by the CDC. They might consider screening for trichomoniasis, bacterial vaginosis, herpes simplex, human papillomavirus and HIV.
For men who have sex with men, the CDC recommends HIV and syphilis serology, urine/pharyngeal/rectal gonorrhea nucleic acid amplification test (NAAT), urine/rectal chlamydia NAAT, and hepatitis C screening for those who are HIV-positive—all at least once a year.
For transgender patients, doctors need to assess their STI- and HIV-related risks based on their current anatomy and sexual behaviors.
Doctors should also consider discussing pre-exposure prophylaxis (PrEP) for any youth at high risk for HIV infection if they are at least 77 pounds (35 kg). Emtricitabine/tenofovir (Truvada, Descovy) reduces the chance of sexually acquired infection by 99%, and infection acquired via drug injection by 74% when taken as prescribed.
Resources
Dr Finger noted a range of resources for LGBTQ youth and their families and providers, including the Family Acceptance Project, Gay and Lesbian Medical Association, Gay, Lesbian and Straight Education Network, GLBTQ Legal Advocates and Defenders (GLAD), Human Rights Campaign, It Gets Better Project, LGBTQ Student Resources and Support, National Center for Lesbian Rights, Parents and Friends of Lesbians and Gays (PFLAG), Safe Schools Coalition and The Trevor Project (concerning suicide risk).
NEW ORLEANS – One of the most important things pediatricians can do to support their lesbian, gay, bisexual, transgender (LGBT) and other gender-nonconforming patients is to ask all their patients about their feelings, preferences and experiences when it comes to gender and sexuality, according to Julie Finger, MD, MPH.
It’s equally important not to make assumptions, she told attendees at the annual meeting of the American Academy of Pediatrics. Biology and sexual and gender identity and expression can be very diverse, she said. Specifically, doctors should not assume patients are heterosexual, that bisexuality is a phase, that orientation or attraction translates directly to behavior or vice versa, or that LGBTQ patients have unsupportive families or are engaging in risky behavior. Research suggests LGB youth have slightly higher rates of early sexual debut, sexual activity or multiple partners than straight or uncertain youth, but only marginally so.
Pediatricians also cannot assume a patient’s sexual orientation based on their partner’s gender or determine a patient’s sexual orientation or gender identity based on appearance – or even that either is the same as it was on the previous visit.
What doctors can be sure of is that they do have LGBTQ patients, said Dr. Finger, and assistant professor of clinical pediatrics at Tulane University in New Orleans. According to a 2016 Morbidity and Mortality Weekly Report (2016 Aug 12; 65[9]), about 1 in 10 students in grades 9-12 are a sexual minority. About 2% of respondents identify as gay or lesbian, 6% identify as bisexual and 3% say they aren’t sure.
Knowing the terminology
Dr. Finger defined key terminology regarding gender and sexuality. She first clarified that LGBT is not the full spectrum for sexual orientation. Pansexual (fluid attraction to any sex or gender) and asexual (lack of feeling sexual attraction) can also describe sexuality, and the Q on the end of LGBTQ is often an umbrella term for “queer” or “questioning” that encompasses anyone who fits outside conventional social norms of sexual identity and gender expression.
Sexual behaviors – which include “young men who have sex with men” and “young women who have sex with women” – do not necessarily correspond as one might expect with sexual orientation or identity, which is one’s concept of their romantic or sexual feelings, attractions and desires, again reinforcing the importance of asking patients their identity and preferences.
In terms of gender, a person’s natal or biologic gender is the one assigned people at birth based on their body parts and hormones. Gender identity is a person’s understanding of their own gender, and gender expression refers to how someone acts or presents themselves and communicates their gender within their culture.
Those who identify as “gender nonconforming, genderqueer, gender fluid, or nonbinary” see their gender on a spectrum, not within the binary “male” or “female.” A cisgender person’s gender identity matches both their biological sex assigned at birth and conventional cultural norms, while a transgender person’s gender differs from the sex they were assigned at birth. Transgender women (male to female, MTF) and men (female to men, FTM) go through the process of transition, a time that can occur in weeks or years when they shift from living as one gender to another.
While it’s unclear what leads to a person’s sexual orientation – likely a combination of genetic, hormonal and environmental factors—there is no question that sexual orientation is not a “choice,” Dr Finger said. Research has also clarified that one’s sexual orientation does not result from parenting behaviors or a history of sexual abuse.
“But I would urge all of you, instead of focusing on why someone is LGBTQ, to focus on what that means for them in their life,” Dr Finger said. “How is this bearing out in terms of their relationships and their behaviors, and how do they feel about it? How are they being supported by their family or their community, and how is it impacting their lives?”
She cited findings from a Human Rights Campaign survey in 2012 of 10,000 youth aged 13-17, which found that most LGBTQ respondents became aware of their same-sex attraction at 9 years of age, though the average age of disclosures is 16, an improvement from age 21 in the 1980s.
How and what to ask
Although children start becoming conscious of gender at ages 1-2, their sense of gender usually stabilizes by age 4.
“Who should we be screening for gender nonconformity? Quite frankly, all children, because all of them have some gender identity, so we should be asking them about that,” Dr Finger said.
When children are younger, doctors can ask parents about their child’s social interactions, forms of play, dress preferences, and mood. Questions for patients themselves, adapted for their age, might include, “Do you feel more like a girl, boy, neither or both?”, “How would you like to play, cut your hair and dress?” And “What name or pronoun (he or she) fits you?”
While such conversations do not necessarily need to happen annually, doctors should especially ask youth who dress or behave in non–gender-conforming ways or who appear to have mood, behavior or social difficulties.
To understand a patient’s sexuality, ask whether they are attracted to people of their own gender or sex, a different gender or sex, both or all genders or no one, or if they’re not sure yet. Doctors can then ask how comfortable they are with their attraction and whether they have told family members or friends about them.
Sexual behavior questions should be developmentally appropriate and lead to counsel but not judgment, Dr Finger said. Her method, with adjustments for age and development, starts, “There are many way of being sexual or intimate with someone: kissing, hugging and touching, and oral sex, anal sex and vaginal sex. Have you ever had any of these experiences? Which ones? With males or females or both, or other genders?”
Then she gets more specific while remaining sensitive. Doctors can ask younger children if they have held hands or cuddled with someone, if they have kissed someone, or if they have touched another person’s private parts. They can ask teens about oral sex, vaginal sex and anal sex and then gather more details about what parts went where, which helps determine what screenings or treatment options a patient may need or desire.
Doctors can use their judgment about whether to ask questions with parents in the room or not, but as kids grow older, it’s good practice to speak to patients without their caregivers present. Doctors should also explain the rules of confidentiality to their patients and be aware of the risks of “coming out,” including family discord or rejection, problems at school or work, social stigma, bullying and harassment, physical violence and risk-taking behaviors, such as substance use, self-injury and risky sexual behaviors. A HEADSSS screen can help doctors learn if any of these are present.
Making your practice inclusive and welcoming
Fewer than one in five teens who are “out” as LGBTQ have come out to their doctor, Dr Finger cited. Most are out to their friends and classmates, and more than half are out to their family, but teens are less likely to tell their doctors.
Research suggests one reason for this is the fact that pediatricians often don’t ask. One study found that only 20% of pediatricians discussed sexual orientation with their patients (Pediatrics 2010 Apr;125:e741-7). Similarly, only 30% of family physicians brought up sexual orientation, found another study (Fam. Med. 2001 May;33[5]:376-81). The studies found physicians more often discussed condoms, HIV, sexually transmitted infections, abstinence, violence, contraception or, in the case of family physicians, sexual behaviors, and relationships.
But another reason for not being out to doctors is a history of poor experiences. A Lambda Legal Survey in 2009 of 4,916 LGBT respondents found that 8% of LGB and 27% of transgender and gender nonconforming patients had been denied care because of their identity of orientation. Eleven percent said “providers refused to touch them or used excessive precautions,” Dr Finger reported. LGBTQ patients may fear the doctor’s reaction or not keeping their identity confidential. Patients may also have internalized shame or guilt due to societal norms or homophobia, and all these barriers can reduce LGBTQ people’s willingness to seek and access to competent care.
The first step to making LGBTQ patients comfortable in your practice is to confront your own personal biases, Dr Finger said. Understand what they are and that a provider’s discomfort, even unconscious, can be damaging to the patient-provider relationship.
“If you find that this is just not something that you’re going to be comfortable doing, at the very least, I would suggest that you find providers in your area who are comfortable working with this patient population and you refer your patients to them so that they can have a good, trusting patient-provider relationship with somebody who can provide the care that they need,” Dr Finger said.
The next step is creating a safe place with zero tolerance for insensitivity by training staff to be welcoming and inclusive, assuring patients confidentiality, providing support and resources and displaying LGBTQ-affirming materials. These youth need active, visible evidence that the office will be a safe place for them.
Ways pediatricians can communicate an inclusive environment include having gender-neutral restrooms, using “parent” instead of “mother/father” and using forms and EMR prompts with gender-neutral language or multiple options for gender selection.
Screening and LGBTQ patients’ health needs
LGB youth and those who aren’t sure of their sexual orientation tend to have higher rates of substance use, including tobacco, alcohol and illicit drugs, and are more often victims of rape and other sexual violence. Their rates of depressive symptoms, bullying victimization, and suicidality are also significantly higher than in their heterosexual cisgender peers. Homelessness rates are also considerably higher in LGBTQ youth than in heterosexual cisgender youth.
One thing pediatricians can do is work with parents to ensure a patient’s school is meeting their needs. The greater risks LGBTQ youth typically face are mediated by social support, resiliency, supportive friends and family and a supportive school environment, including inclusive curricula and supportive staff.
Lesbian and bisexual women are considerably more at risk for poor sexual or reproductive outcomes, Dr Finger said. Their rates of unplanned pregnancy are double that of straight women, contributing to their higher rates of emergency contraception and abortion. They are also more likely to have more partners (male and females), to have a younger sexual debut and to be forced into sex by a male partner—yet they are far less likely to perceive themselves as at risk for a sexually transmitted infection than their peers.
This patient population therefore may need contraception counseling, including discussing their current methods and reviewing their options, including emergency contraception and possibly an advance prescription. Dr Finger also suggests having male and female condoms available in the office.
Doctors should screen all their female patients, regardless of sexuality, for chlamydia and gonorrhea, and offer routine cervical cancer screening and the HPV vaccine, as recommended by the CDC. They might consider screening for trichomoniasis, bacterial vaginosis, herpes simplex, human papillomavirus and HIV.
For men who have sex with men, the CDC recommends HIV and syphilis serology, urine/pharyngeal/rectal gonorrhea nucleic acid amplification test (NAAT), urine/rectal chlamydia NAAT, and hepatitis C screening for those who are HIV-positive—all at least once a year.
For transgender patients, doctors need to assess their STI- and HIV-related risks based on their current anatomy and sexual behaviors.
Doctors should also consider discussing pre-exposure prophylaxis (PrEP) for any youth at high risk for HIV infection if they are at least 77 pounds (35 kg). Emtricitabine/tenofovir (Truvada, Descovy) reduces the chance of sexually acquired infection by 99%, and infection acquired via drug injection by 74% when taken as prescribed.
Resources
Dr Finger noted a range of resources for LGBTQ youth and their families and providers, including the Family Acceptance Project, Gay and Lesbian Medical Association, Gay, Lesbian and Straight Education Network, GLBTQ Legal Advocates and Defenders (GLAD), Human Rights Campaign, It Gets Better Project, LGBTQ Student Resources and Support, National Center for Lesbian Rights, Parents and Friends of Lesbians and Gays (PFLAG), Safe Schools Coalition and The Trevor Project (concerning suicide risk).
EXPERT ANALYSIS FROM AAP 2019
